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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AL-4943A Ophthalmic Solution Administered Once Daily

    Summary
    EudraCT number
    		 2017-002728-26
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    29 Jan 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Dec 2017
    First version publication date
    21 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C-12-028
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01698814
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alcon Research
    Sponsor organisation address
    6201 S. Freeway, Fort Worth, United States, 76134
    Public contact
    Ophthalmology Unit, Novartis Pharmaceuticals, +44 0127666733391, Dennis.wong@novartis.com
    Scientific contact
    Ophthalmology Unit, Novartis Pharmaceuticals, +44 0127666733391, Dennis.wong@novartis.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jan 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jan 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Jan 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks.
    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
    15 Oct 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
    United States: 499
    Worldwide total number of subjects
    499
    EEA total number of subjects
    0
    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)
    68
    Adolescents (12-17 years)
    7
    Adults (18-64 years)
    413
    From 65 to 84 years
    11
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 15 study centers located in the United States.

    Pre-assignment
    Screening details
    		 This reporting group includes all randomized and treated subjects (499).

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AL-4943A
    Arm description
    		 AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    AL-4943A Ophthalmic Solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    One drop instilled in both eyes once daily for up to 6 weeks

    Arm title
    		 AL-4943A Vehicle
    Arm description
    		 AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
    Arm type
    		 Placebo Comparator

    Investigational medicinal product name
    AL-4943A Ophthalmic Solution Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    One drop instilled in both eyes once daily for up to 6 weeks

    Number of subjects in period 1
    		AL-4943A AL-4943A Vehicle
    Started
    330
    169
    Completed
    329
    166
    Not completed
    1
    3
         Adverse event, non-fatal
    -
    2
         Pregnancy
    1
    -
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AL-4943A
    Reporting group description
    		 AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks

    Reporting group title
    AL-4943A Vehicle
    Reporting group description
    		 AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks

    Reporting group values
    		 AL-4943A AL-4943A Vehicle Total
    Number of subjects
    		 330 169 499
    Age categorical
    Units: Subjects
        2-11 years
    		 47 21 68
        12-17 years
    		 4 3 7
        18-64
    		 272 141 413
        ≥65 years
    		 7 4 11
    Gender categorical
    Units: Subjects
        Female
    		 214 111 325
        Male
    		 116 58 174

    End points

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    End points reporting groups
    Reporting group title
    AL-4943A
    Reporting group description
    		 AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks

    Reporting group title
    AL-4943A Vehicle
    Reporting group description
    		 AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks

    Primary: Adverse Events

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    End point title
    		 Adverse Events [1]
    End point description
    An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator. This reporting group includes all randomized subjects who received study medication.
    End point type
    Primary
    End point timeframe
    An average of 6 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypothesis testing was planned or conducted.
    End point values
    		 AL-4943A AL-4943A Vehicle
    Number of subjects analysed
    330
    169
    Units: Participants
    number (not applicable)
        Deaths
    0
    0
        Non-Fatal Serious Adverse Events
    0
    0
        Discontinuations Due to an Adverse Event
    0
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse Events (AE) were collected for the duration of the study (3 months).
    Adverse event reporting additional description
    An AE was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. This reporting group includes all randomized subjects who received study medication. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    AL-4943A
    Reporting group description
    		 AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks

    Reporting group title
    AL-4943A Vehicle
    Reporting group description
    		 AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks

    Serious adverse events
    		 AL-4943A AL-4943A Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 169 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AL-4943A AL-4943A Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 330 (0.00%)
    0 / 169 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events occurred above the 5% threshold.

    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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