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    Clinical Trial Results:
    A PHASE 3 PROSPECTIVE, RANDOMIZED, DOUBLE-MASKED, 12-WEEK,PARALLEL GROUP STUDY EVALUATING THE EFFICACY AND SAFETY OF LATANOPROST AND TIMOLOL IN PAEDIATRIC SUBJECTS WITH GLAUCOMA.

    Summary
    EudraCT number
    		 2007-004543-30
    Trial protocol
    		 GB   DE   ES   IT   SI   BE   PT   FR   CZ   SK   DK   GR   Outside EU/EEA  
    Global end of trial date
    11 Nov 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    30 Jul 2016
    First version publication date
    11 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    corrections required

    Trial information

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    Trial identification
    Sponsor protocol code
    A6111137
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00716859
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000011-PIP01-07
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Jan 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the relative effectiveness of latanoprost 0.005 percent (%) ophthalmic solution dosed once-daily and timolol 0.5% (or optionally 0.25% for subjects younger than 3 years old) dosed twice-daily in paediatric subjects less than or equal to (<=)18 years of age who are diagnosed with paediatric glaucoma. Specifically, to demonstrate that latanoprost is not inferior to timolol within a non-inferiority margin of 3 millimeters of mercury (mmHg), with an option of switching to superiority, in the event that the lower limit of the 95% confidence interval (CI) for the treatment difference not only lies above the non-inferiority margin but also above zero.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Jul 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Portugal: 12
    Country: Number of subjects enrolled
    Romania: 1
    Country: Number of subjects enrolled
    Russian Federation: 4
    Country: Number of subjects enrolled
    Serbia: 5
    Country: Number of subjects enrolled
    Slovakia: 12
    Country: Number of subjects enrolled
    Slovenia: 2
    Country: Number of subjects enrolled
    South Africa: 1
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    Ukraine: 24
    Country: Number of subjects enrolled
    United Kingdom: 5
    Country: Number of subjects enrolled
    United States: 10
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Philippines: 10
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Colombia: 3
    Country: Number of subjects enrolled
    Czech Republic: 5
    Country: Number of subjects enrolled
    France: 9
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    India: 2
    Worldwide total number of subjects
    137
    EEA total number of subjects
    78
    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)
    23
    Children (2-11 years)
    66
    Adolescents (12-17 years)
    45
    Adults (18-64 years)
    3
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Randomization was stratified by age, diagnosis (congenital glaucoma [PCG] or non-congenital glaucoma [non-PCG], and intraocular pressure [IOP]) of the study eye at baseline.

    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
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Timolol
    Arm description
    		 Timolol maleate ophthalmic solution was administered.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Timolol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Subjects received 1 drop of Timolol 0.5% (or optionally 0.25% for subjects younger than 3 years old) at approximately 8 AM and again at approximately 8 PM.

    Arm title
    		 Latanoprost
    Arm description
    		 Latanoprost ophthalmic solution and vehicle was administered.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Latanoprost
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Subjects received 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.

    Number of subjects in period 1
    		Timolol Latanoprost
    Started
    69
    68
    Completed
    61
    64
    Not completed
    8
    4
         Consent withdrawn by subject
    1
    3
         Lack of Efficacy
    3
    -
         Adverse Event
    4
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Timolol
    Reporting group description
    		 Timolol maleate ophthalmic solution was administered.

    Reporting group title
    Latanoprost
    Reporting group description
    		 Latanoprost ophthalmic solution and vehicle was administered.

    Reporting group values
    		 Timolol Latanoprost Total
    Number of subjects
    		 69 68 137
    Age categorical
    Units: Subjects
        12 to 18 years
    		 23 25 48
        3 to less than (<) 12 years
    		 29 26 55
        0 to < 3 years
    		 17 17 34
    Gender categorical
    Units: Subjects
        Female
    		 37 34 71
        Male
    		 32 34 66

    End points

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    End points reporting groups
    Reporting group title
    Timolol
    Reporting group description
    		 Timolol maleate ophthalmic solution was administered.

    Reporting group title
    Latanoprost
    Reporting group description
    		 Latanoprost ophthalmic solution and vehicle was administered.

    Primary: Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)

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    End point title
    		 Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
    End point description
    Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were <= 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Per Protocol (PP) Population: subjects with no major protocol violations who received at least 1 week of study medication and had at least Week 1 IOP measurements. LOCF.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Timolol Latanoprost
    Number of subjects analysed
    54
    53
    Units: mmHg
        least squares mean (standard error)
    5.72 ( 0.81 )
    7.18 ( 0.81 )
    Statistical analysis title
    		 All groups
    Statistical analysis description
    Null hypothesis: latanoprost inferior to timolol (0.5 % optionally 0.25% for subjects younger than 3 years). Power calculation: assuming common standard deviation (7 mmHg), 110 subjects have 84% power to demonstrate latanoprost not inferior to timolol within 3 mmHg margin, assuming latanoprost has 1 mmHg reduction more than timolol in mean change from baseline IOP.
    Comparison groups
    Timolol v Latanoprost
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.81
         upper limit
    		 3.74
    Notes
    [1] - If lower limit of 95% CI for treatment difference is above non-inferiority margin, then non-inferiority concluded. If lower limit of 95% CI for treatment difference is above non-inferiority margin and above zero, then superiority concluded. The difference and 95% CI of the difference in IOP reduction (Week 12) was computed from an analysis of covariance (ANCOVA) model with treatment and baseline diagnosis as factors and baseline IOP as covariate.

    Secondary: Reduction From Baseline in Mean IOP at Week 1

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    End point title
    		 Reduction From Baseline in Mean IOP at Week 1
    End point description
    Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were <= 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Per protocol population was analysed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 1
    End point values
    		 Timolol Latanoprost
    Number of subjects analysed
    54
    53
    Units: mmHg
        least squares mean (standard error)
    6.02 ( 0.83 )
    6.7 ( 0.84 )
    Statistical analysis title
    		 All groups
    Comparison groups
    Timolol v Latanoprost
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.66
         upper limit
    		 3.02

    Secondary: Reduction From Baseline in Mean IOP at Week 4

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    End point title
    		 Reduction From Baseline in Mean IOP at Week 4
    End point description
    Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were <= 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Evaluable subjects in Per protocol population were analysed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Timolol Latanoprost
    Number of subjects analysed
    47
    49
    Units: mmHg
        least squares mean (standard error)
    5.37 ( 0.94 )
    6.99 ( 0.92 )
    Statistical analysis title
    		 All groups
    Comparison groups
    Timolol v Latanoprost
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 4.25

    Secondary: Reduction From Baseline in Mean IOP at Week 12 (Observed)

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    End point title
    		 Reduction From Baseline in Mean IOP at Week 12 (Observed)
    End point description
    Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were <= 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Evaluable subjects in Per protocol population were analysed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 Timolol Latanoprost
    Number of subjects analysed
    43
    46
    Units: mmHg
        least squares mean (standard error)
    6.96 ( 0.68 )
    7.75 ( 0.66 )
    Statistical analysis title
    		 All groups
    Comparison groups
    Timolol v Latanoprost
    Number of subjects included in analysis
    89
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 2.67

    Secondary: Mean IOP at Baseline

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    End point title
    		 Mean IOP at Baseline
    End point description
    IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were <=2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Per protocol population was analysed.
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Timolol Latanoprost
    Number of subjects analysed
    54
    53
    Units: mmHg
        arithmetic mean (standard deviation)
    27.8 ( 6.18 )
    27.3 ( 5.46 )
    No statistical analyses for this end point

    Secondary: Mean IOP at Week 1

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    End point title
    		 Mean IOP at Week 1
    End point description
    IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were <= 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Per protcol population was analysed.
    End point type
    Secondary
    End point timeframe
    Week 1
    End point values
    		 Timolol Latanoprost
    Number of subjects analysed
    54
    53
    Units: mmHg
        arithmetic mean (standard deviation)
    21.7 ( 7.99 )
    20.6 ( 6.38 )
    No statistical analyses for this end point

    Secondary: Mean IOP at Week 4

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    End point title
    		 Mean IOP at Week 4
    End point description
    IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were <= 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Evaluable subjects in per protocol population were analysed.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Timolol Latanoprost
    Number of subjects analysed
    47
    49
    Units: mmHg
        arithmetic mean (standard deviation)
    21.5 ( 7.49 )
    20.1 ( 6.82 )
    No statistical analyses for this end point

    Secondary: Mean IOP at Week 12

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    End point title
    		 Mean IOP at Week 12
    End point description
    IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were <= 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Evaluable subjects in per protocol population.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Timolol Latanoprost
    Number of subjects analysed
    43
    46
    Units: mmHg
        arithmetic mean (standard deviation)
    19.8 ( 3.5 )
    19.2 ( 5.87 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Greater Than or Equal to (>=) 15% IOP Reduction From Baseline at Both Weeks 4 and 12

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    End point title
    		 Percentage of Subjects With Greater Than or Equal to (>=) 15% IOP Reduction From Baseline at Both Weeks 4 and 12
    End point description
    Subjects with >= 15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were <=2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded. Evaluable subjects in Per protocol population were analysed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, Week 12
    End point values
    		 Timolol Latanoprost
    Number of subjects analysed
    54
    53
    Units: percentage of subjects
        number (confidence interval 95%)
    52 (38 to 66)
    60 (46 to 74)
    Statistical analysis title
    		 All groups
    Statistical analysis description
    P-value from a Cochran-Mantel-Haenszel chi-square test stratified by baseline diagnosis (PCG vs non-PCG).
    Comparison groups
    Timolol v Latanoprost
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3315
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Percentage of Subjects Discontinuing Therapy Due to a Drug-related Adverse Experience

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    End point title
    		 Percentage of Subjects Discontinuing Therapy Due to a Drug-related Adverse Experience
    End point description
    An investigator’s causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as “related to investigational product” for reporting purposes. Intent to treat (ITT) population: all subjects who were randomized into the study and received at least 1 dose of study medication.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 12
    End point values
    		 Timolol Latanoprost
    Number of subjects analysed
    69
    68
    Units: percentage of subjects
        number (not applicable)
    1.4
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 30 days after last study treatment administration
    Adverse event reporting additional description
    Same event may appear as AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 subject and non serious in another, or 1 subject may have experienced both serious, non serious event during study. EU BR specific AE tables were generated separately as per EU format using the latest coding dictionary.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Timolol
    Reporting group description
    		 Timolol maleate ophthalmic solution; 1 drop of timolol 0.5% (or optionally 0.25% for subjects younger than 3 years old) at approximately 8 AM and again at approximately 8 PM .

    Reporting group title
    Latanoprost
    Reporting group description
    		 Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.

    Serious adverse events
    		 Timolol Latanoprost
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 69 (10.14%)
    2 / 68 (2.94%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Congenital, familial and genetic disorders
    Developmental glaucoma
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Trabeculectomy
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Angle closure glaucoma
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal perforation
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye haemorrhage
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lens dislocation
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 68 (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
    1 / 69 (1.45%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 68 (1.47%)
         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 / 69 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 69 (1.45%)
    0 / 68 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 68 (1.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Timolol Latanoprost
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 69 (30.43%)
    15 / 68 (22.06%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 69 (5.80%)
    2 / 68 (2.94%)
         occurrences all number
    5
    2
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 69 (2.90%)
    2 / 68 (2.94%)
         occurrences all number
    2
    2
    Therapeutic response changed
         subjects affected / exposed
    0 / 69 (0.00%)
    2 / 68 (2.94%)
         occurrences all number
    0
    3
    Eye disorders
    Conjunctival disorder
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 68 (0.00%)
         occurrences all number
    2
    0
    Conjunctival hyperaemia
         subjects affected / exposed
    6 / 69 (8.70%)
    3 / 68 (4.41%)
         occurrences all number
    7
    4
    Corneal oedema
         subjects affected / exposed
    1 / 69 (1.45%)
    2 / 68 (2.94%)
         occurrences all number
    1
    2
    Visual acuity reduced
         subjects affected / exposed
    2 / 69 (2.90%)
    0 / 68 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Influenza
         subjects affected / exposed
    4 / 69 (5.80%)
    0 / 68 (0.00%)
         occurrences all number
    5
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 69 (7.25%)
    4 / 68 (5.88%)
         occurrences all number
    5
    4
    Rhinitis
         subjects affected / exposed
    1 / 69 (1.45%)
    2 / 68 (2.94%)
         occurrences all number
    1
    2
    Viral infection
         subjects affected / exposed
    2 / 69 (2.90%)
    1 / 68 (1.47%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Oct 2007
    1) Removal of the follow-up visit 1 week after end of treatment was made. 2) Confirmation that discontinuation of any topical or systemic ocular hypotensive medications should be completed at least 24 hours before the Baseline visit was made.

    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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