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    Clinical Trial Results:
    A 2-year, Multicenter, Double-masked, Randomized, Parallel Study of the Safety of LUMIGAN® 0.1 mg/mL Compared with LUMIGAN® 0.3 mg/mL in Patients with Glaucoma or Ocular Hypertension

    Summary
    EudraCT number
    		 2010-023917-68
    Trial protocol
    		 DE   HU   GB   ES   CZ   BE   IT  
    Global end of trial date
    06 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jan 2018
    First version publication date
    20 Jan 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    192024-054
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01298700
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergan, Inc
    Sponsor organisation address
    Marlow International, The Parkway, Marlow, Buckinghamshire, United Kingdom, SL7 1YL
    Public contact
    Therapeutic Area Head, Allergan, Inc, +1 7142464500,
    Scientific contact
    Therapeutic Area Head, Allergan, Inc, +1 7142464500, clinicaltrials@allergan.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.
    Protection of trial subjects
    All participants were required to read and sign an informed consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 May 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 153
    Country: Number of subjects enrolled
    Czech Republic: 51
    Country: Number of subjects enrolled
    Germany: 57
    Country: Number of subjects enrolled
    Spain: 193
    Country: Number of subjects enrolled
    France: 15
    Country: Number of subjects enrolled
    United Kingdom: 117
    Country: Number of subjects enrolled
    Hungary: 33
    Country: Number of subjects enrolled
    Israel: 60
    Country: Number of subjects enrolled
    Italy: 57
    Country: Number of subjects enrolled
    Poland: 70
    Worldwide total number of subjects
    806
    EEA total number of subjects
    746
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    441
    From 65 to 84 years
    359
    85 years and over
    6

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 806
    Number of subjects completed
    		 798

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Did not Receive Treatment: 8
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bimatoprost 0.01% Ophthalmic Solution
    Arm description
    		 One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bimatoprost 0.01% Ophthalmic Solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    1 drop in each eye once daily in the evening.

    Arm title
    		 Bimatoprost 0.03% Ophthalmic Solution
    Arm description
    		 One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Bimatoprost 0.03% Ophthalmic Solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    1 drop in each eye once daily in the evening.

    Number of subjects in period 1 [1]
    		Bimatoprost 0.01% Ophthalmic Solution Bimatoprost 0.03% Ophthalmic Solution
    Started
    400
    398
    Completed
    302
    303
    Not completed
    98
    95
         Consent withdrawn by subject
    12
    9
         Adverse event, non-fatal
    50
    51
         Lost to follow-up
    5
    2
         Other Miscellaneous Reasons
    16
    15
         Lack of efficacy
    9
    14
         Protocol deviation
    6
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline Period is based on the Safety Population that included all participants who received at least one dose of study drug.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bimatoprost 0.01% Ophthalmic Solution
    Reporting group description
    		 One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

    Reporting group title
    Bimatoprost 0.03% Ophthalmic Solution
    Reporting group description
    		 One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

    Reporting group values
    		 Bimatoprost 0.01% Ophthalmic Solution Bimatoprost 0.03% Ophthalmic Solution Total
    Number of subjects
    		 400 398 798
    Age Categorical
    Units: Subjects
        < 45 years
    		 22 26 48
        ≥ 45 years to ≤ 65 years
    		 216 211 427
        > 65 years
    		 162 161 323
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.7 ( 11.0 ) 62.2 ( 11.5 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 197 187 384
        Male
    		 203 211 414

    End points

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    End points reporting groups
    Reporting group title
    Bimatoprost 0.01% Ophthalmic Solution
    Reporting group description
    		 One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

    Reporting group title
    Bimatoprost 0.03% Ophthalmic Solution
    Reporting group description
    		 One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

    Primary: Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events

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    End point title
    		 Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported.
    End point type
    Primary
    End point timeframe
    24 Months
    End point values
    		 Bimatoprost 0.01% Ophthalmic Solution Bimatoprost 0.03% Ophthalmic Solution
    Number of subjects analysed
    400
    398
    Units: percentage of participants
        number (not applicable)
    33.3
    37.7
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Bimatoprost 0.01% Ophthalmic Solution v Bimatoprost 0.03% Ophthalmic Solution
    Number of subjects included in analysis
    798
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.148 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -4.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 1.9
    Notes
    [1] - P-value was stratified by baseline prostaglandin analogue (PGA) treatment(yes/no) and by baseline active ocular surface finding (present/absent).

    Secondary: Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events excluding "Conjunctival Hyperemia"

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    End point title
    		 Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events excluding "Conjunctival Hyperemia"
    End point description
    An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator excluding AEs with the preferred term Conjunctival hyperemia are reported.
    End point type
    Secondary
    End point timeframe
    24 Months
    End point values
    		 Bimatoprost 0.01% Ophthalmic Solution Bimatoprost 0.03% Ophthalmic Solution
    Number of subjects analysed
    400
    398
    Units: percentage of participants
        number (not applicable)
    26.0
    29.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 Months
    Adverse event reporting additional description
    Safety Population, all participants who received at least one dose of study drug, was used to determine the number of participants at risk for Serious and Non-serious Adverse Events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Bimatoprost 0.01% Ophthalmic Solution
    Reporting group description
    		 One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

    Reporting group title
    Bimatoprost 0.03% Ophthalmic Solution
    Reporting group description
    		 One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

    Serious adverse events
    		 Bimatoprost 0.01% Ophthalmic Solution Bimatoprost 0.03% Ophthalmic Solution
    Total subjects affected by serious adverse events
         subjects affected / exposed
    45 / 400 (11.25%)
    40 / 398 (10.05%)
         number of deaths (all causes)
    4
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 400 (0.25%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hodgkin’s disease
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip squamous cell carcinoma
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubular breast carcinoma
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lung
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arteriosclerosis
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Inguinal hernia repair
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Catheter site inflammation
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal prolapse
         subjects affected / exposed [1]
    1 / 197 (0.51%)
    0 / 187 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed [2]
    0 / 203 (0.00%)
    1 / 211 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Investigations
    Intraocular pressure fluctuation
         subjects affected / exposed
    4 / 400 (1.00%)
    2 / 398 (0.50%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraocular pressure increased
         subjects affected / exposed
    1 / 400 (0.25%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary contusion
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urostomy complication
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    2 / 400 (0.50%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    2 / 400 (0.50%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery thrombosis
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    2 / 400 (0.50%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Partial seizures
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 400 (0.25%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    2 / 400 (0.50%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angle closure glaucoma
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract cortical
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous adhesions
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic neuropathy
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal haemorrhage
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 400 (0.00%)
    2 / 398 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett’s oesophagus
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis relapsing
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal haematoma
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 400 (0.00%)
    2 / 398 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder prolapse
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 400 (0.25%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal disorder
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Echinococciasis
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    0 / 400 (0.00%)
    1 / 398 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    1 / 400 (0.25%)
    0 / 398 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Adverse Event is gender specific and includes only female participants.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Adverse Event is gender specific and includes only male participants.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Bimatoprost 0.01% Ophthalmic Solution Bimatoprost 0.03% Ophthalmic Solution
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    167 / 400 (41.75%)
    186 / 398 (46.73%)
    Eye disorders
    Blepharitis
         subjects affected / exposed
    14 / 400 (3.50%)
    23 / 398 (5.78%)
         occurrences all number
    30
    44
    Cataract
         subjects affected / exposed
    20 / 400 (5.00%)
    24 / 398 (6.03%)
         occurrences all number
    33
    37
    Conjunctival hyperaemia
         subjects affected / exposed
    80 / 400 (20.00%)
    90 / 398 (22.61%)
         occurrences all number
    153
    195
    Dry eye
         subjects affected / exposed
    36 / 400 (9.00%)
    42 / 398 (10.55%)
         occurrences all number
    68
    81
    Eye pain
         subjects affected / exposed
    21 / 400 (5.25%)
    20 / 398 (5.03%)
         occurrences all number
    40
    37
    Foreign body sensation in eyes
         subjects affected / exposed
    11 / 400 (2.75%)
    21 / 398 (5.28%)
         occurrences all number
    18
    37
    Punctate keratitis
         subjects affected / exposed
    22 / 400 (5.50%)
    30 / 398 (7.54%)
         occurrences all number
    44
    51
    Infections and infestations
    Influenza
         subjects affected / exposed
    26 / 400 (6.50%)
    21 / 398 (5.28%)
         occurrences all number
    30
    21

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Nov 2010
    Amendment 1: The protocol was amended to change the procedure for measuring Tear Breakup Time (TBUT) due to the lack of wide availability of the originally planned test material, and to allow the use of an additional method for corneal pachymetry. Other changes were made to enhance consistency and clarity throughout the document, and to provide additional details about procedures. The amendment was implemented prior to enrollment of any patients into the study.
    11 Mar 2013
    Amendment 2: The protocol was amended to provide clarity for treatment randomization and stratification by using a flow diagram rather than the text description. Other changes were made to enhance consistency and clarity throughout the document, and to provide additional details about VF examination. In addition, the estimated number of sites was updated from 20-25 to 50 to reflect the current plans for study enrollment.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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