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    Clinical Trial Results:
    A 3 Month, Multicenter, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients

    Summary
    EudraCT number
    		 2012-001324-34
    Trial protocol
    		 BE   GB   PL   DE   PT   NL   ES  
    Global end of trial date
    25 Mar 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C-12-008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01664039
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alcon Research, Ltd.
    Sponsor organisation address
    6201 S. Freeway, Fort Worth, Texas, United States, 76134
    Public contact
    Head, Pharma, GCRA, Alcon Research, Ltd. , +1 888-451-3937, alcon.medinfo@alcon.com
    Scientific contact
    Head, Pharma, GCRA, Alcon Research, Ltd., +1 888-451-3937, alcon.medinfo@alcon.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001271-PIP01-12
    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
    25 Mar 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Mar 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Mar 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to demonstrate that the IOP-lowering efficacy of Travoprost Ophthalmic Solution, 0.004% (preserved with POLYQUAD) is noninferior to Timolol Ophthalmic Solution (0.5% or 0.25%) in pediatric glaucoma patients.
    Protection of trial subjects
    Prior to the start of the study, the study protocol, the informed consent and assent documents, patient instruction sheets, the Investigator’s Brochure, as well as any advertising materials used to recruit patients were submitted to institutional review boards (IRBs) and independent ethics committees (IECs). The IRB/IECs reviewed all documents and approved required documents; copies of the approval letters were provided to Alcon. Consistent with both the IRB/IEC’s requirements and all applicable regulations, the Investigators periodically provided study updates to the IRB/IEC. A patient or parent/legal guardian (if necessary, a legally authorized representative) provided informed consent, and children signed an approved assent form when appropriate. This study was conducted in accordance with Good Clinical Practices (GCP) and the ethical principles that have their origins in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Sep 2012
    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
    Poland: 5
    Country: Number of subjects enrolled
    Portugal: 1
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    United States: 67
    Country: Number of subjects enrolled
    Colombia: 35
    Country: Number of subjects enrolled
    Mexico: 2
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Saudi Arabia: 3
    Country: Number of subjects enrolled
    Taiwan: 1
    Country: Number of subjects enrolled
    Romania: 15
    Country: Number of subjects enrolled
    Philippines: 10
    Country: Number of subjects enrolled
    Singapore: 3
    Country: Number of subjects enrolled
    United Kingdom: 4
    Worldwide total number of subjects
    152
    EEA total number of subjects
    31
    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)
    10
    Children (2-11 years)
    85
    Adolescents (12-17 years)
    57
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients in this study were enrolled across 38 investigational centers in the United States, Germany, Singapore, United Kingdom, Taiwan, Philippines, Spain, Saudi Arabia, Columbia, France, Portugal, Belgium, Poland, Romania, Puerto Rico, and Mexico.

    Pre-assignment
    Screening details
    		 Of the 184 enrolled, 32 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (152).

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Travoprost
    Arm description
    		 1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
    Arm type
    		 Experimental

    Investigational medicinal product name
    Travoprost 40 μg/mL Eye Drops, Solution preserved with POLYQUAD (PQ)
    Investigational medicinal product code
    Other name
    Travoprost PQ
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Topical use
    Dosage and administration details
    Travoprost 40 μg/mL Eye Drops, solution preserved with POLYQUAD, 1 drop instilled in each eye, once daily in the evening for 3 months

    Arm title
    		 Timolol
    Arm description
    		 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Timolol eye drops
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops
    Routes of administration
    Topical use
    Dosage and administration details
    One drop instilled in each eye, twice daily (morning and evening)

    Number of subjects in period 1
    		Travoprost Timolol
    Started
    77
    75
    Completed
    71
    74
    Not completed
    6
    1
         Treatment failure
    5
    1
         Inadequate IOP control
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Travoprost
    Reporting group description
    		 1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months

    Reporting group title
    Timolol
    Reporting group description
    		 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months

    Reporting group values
    		 Travoprost Timolol Total
    Number of subjects
    		 77 75 152
    Age categorical
    Units: Subjects
        2 months to <3 years
    		 10 6 16
        3 to <12 years
    		 40 39 79
        12 to <18 years
    		 27 30 57
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.2 ± 4.8 10 ± 4.58 -
    Gender categorical
    This analysis population includes all patients who received study drug and completed at least 1 scheduled on-therapy visit.
    Units: Subjects
        Female
    		 40 40 80
        Male
    		 37 35 72

    End points

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    End points reporting groups
    Reporting group title
    Travoprost
    Reporting group description
    		 1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months

    Reporting group title
    Timolol
    Reporting group description
    		 1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months

    Primary: Mean Change from Baseline in IOP at Month 3

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    End point title
    		 Mean Change from Baseline in IOP at Month 3
    End point description
    IOP (fluid pressure inside the eye) was assessed using a calibrated tonometer and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye from each participant was chosen as the study eye and only the study eye was used for analysis.
    End point type
    Primary
    End point timeframe
    Baseline (Day 0), Month 3
    End point values
    		 Travoprost Timolol
    Number of subjects analysed
    71 [1]
    74 [2]
    Units: mmHg
        arithmetic mean (standard error)
    -5.4 ± 0.98
    -5.3 ± 0.93
    Notes
    [1] - Observed cases only.
    [2] - Observed cases only.
    Statistical analysis title
    		 Comparison of Mean IOP Change from Base at Month 3
    Statistical analysis description
    Treatment differences in mean IOP change from baseline were examined with a pairwise test at the Month 3 visit. The pairwise test was based on the least squares means derived from a repeated measures analysis of variance with treatment, visit, primary diagnosis and baseline IOP strata (<27, 27-31, or >31 mmHg) in the model. Non-inferiority of Travoprost 0.004% PQ to Timolol was established if the upper limit of the 95% CI for the difference between treatment groups was less than 3.0 mmHg
    Comparison groups
    Travoprost v Timolol
    Number of subjects included in analysis
    145
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    		 0.05%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 1.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.72

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected for the duration of the study (1 year, 6 months). An AE was defined as any untoward medical occurrence in a patient who is administered a study medication, regardless of causal relationship with the medication.
    Adverse event reporting additional description
    All AEs were obtained as solicited comments from patients and as observations by the study Investigator as outlined in the study protocol. This analysis population includes all randomized participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Travoprost
    Reporting group description
    		 All participants who received travoprost with vehicle

    Reporting group title
    Timolol
    Reporting group description
    		 All participants who received timolol

    Serious adverse events
    		 Travoprost Timolol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 77 (0.00%)
    2 / 75 (2.67%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Infections and infestations
    Keratitis bacterial
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 77 (0.00%)
    1 / 75 (1.33%)
         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: 5%
    Non-serious adverse events
    		 Travoprost Timolol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 77 (28.57%)
    6 / 75 (8.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 77 (6.49%)
    2 / 75 (2.67%)
         occurrences all number
    7
    3
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    15 / 77 (19.48%)
    3 / 75 (4.00%)
         occurrences all number
    18
    3
    Growth of eyelashes
         subjects affected / exposed
    5 / 77 (6.49%)
    0 / 75 (0.00%)
         occurrences all number
    5
    0
    Conjunctival hyperaemia
         subjects affected / exposed
    4 / 77 (5.19%)
    1 / 75 (1.33%)
         occurrences all number
    4
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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