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    Clinical Trial Results:
    A Comparative Study of Olopatadine Hydrochloride Ophthalmic Solution 0.2% QD vs Olopatadine Hydrochloride Ophthalmic Solution 0.1% BID in the Treatment of Allergic Conjunctivitis in Chinese Subjects

    Summary
    EudraCT number
    		 2016-004317-27
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    15 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Sep 2017
    First version publication date
    15 Sep 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C-12-010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02322216
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharmaceuticals
    Sponsor organisation address
    Park View, Riverside way, Watchmoor Park, Camberley , Surrey, United Kingdom, GU15 3YL
    Public contact
    Dennis Wong, Novartis Pharmaceuticals, dennis.wong@novartis.com
    Scientific contact
    Dennis Wong, Novartis Pharmaceuticals, 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
    15 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate olopatadine 0.2% QD (once per day) compared to olopatadine 0.1% BID (twice per day) in the treatment of ocular itching associated with allergic conjunctivitis.
    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
    30 Dec 2014
    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
    China: 252
    Worldwide total number of subjects
    252
    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)
    17
    Adolescents (12-17 years)
    11
    Adults (18-64 years)
    218
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from 10 study centers located in China.

    Pre-assignment
    Screening details
    		 Of the 383 subjects who signed an informed consent form, 130 were exited as screen failures prior to randomization and 253 were randomized. This reporting group includes all randomized and treated subjects (252).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Investigator [1]

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PATADAY
    Arm description
    		 Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olopatadine Hydrochloride Ophthalmic Solution 0.2%
    Investigational medicinal product code
    EXZ829B
    Other name
    PATADAY®
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    Olopatadine hydrochloride ophthalmic solution 0.2% in the morning, 1 drop in each eye for 14 days

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    Olopatadine 0.2% vehicle in the evening, 1 drop in each eye for 14 days

    Arm title
    		 PATANOL
    Arm description
    		 Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Olopatadine Hydrochloride Ophthalmic Solution 0.1%
    Investigational medicinal product code
    Other name
    PATANOL®
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ocular use
    Dosage and administration details
    Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days

    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: This was a single-blind trial and only the investigator was masked.
    Number of subjects in period 1
    		PATADAY PATANOL
    Started
    126
    126
    Completed
    124
    123
    Not completed
    2
    3
         Consent withdrawn by subject
    1
    3
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PATADAY
    Reporting group description
    		 Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days

    Reporting group title
    PATANOL
    Reporting group description
    		 Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days

    Reporting group values
    		 PATADAY PATANOL Total
    Number of subjects
    		 126 126 252
    Age categorical
    Units: Subjects
        10-17 years
    		 14 14 28
        18-64 years
    		 109 109 218
        ≥65 years
    		 3 3 6
    Gender categorical
    This analysis population includes all subjects who received study drug (Safety Analysis Set).
    Units: Subjects
        Female
    		 83 88 171
        Male
    		 43 38 81

    End points

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    End points reporting groups
    Reporting group title
    PATADAY
    Reporting group description
    		 Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days

    Reporting group title
    PATANOL
    Reporting group description
    		 Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days

    Primary: Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14

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    End point title
    		 Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14
    End point description
    Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis. This analysis population includes the Per Protocol Set with non-missing data.
    End point type
    Primary
    End point timeframe
    Baseline, Day 14
    End point values
    		 PATADAY PATANOL
    Number of subjects analysed
    118
    112
    Units: Units on a scale
        arithmetic mean (standard error)
    -2.57 ( 0.09 )
    -2.62 ( 0.092 )
    Statistical analysis title
    		 Change from baseline in mean itching score
    Statistical analysis description
    Treatment difference in mean itching score (worst itching score during 24 hours) change from baseline at Day 14
    Comparison groups
    PATADAY v PATANOL
    Number of subjects included in analysis
    230
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.17
         upper limit
    		 0.26

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected from the time of informed consent and for the duration of participation in the study (2 weeks). This analysis group includes all participants who received study treatment.
    Adverse event reporting additional description
    An AE is defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reports of AEs were obtained through solicited and spontaneous comments from the participants.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    PATADAY
    Reporting group description
    		 All subjects treated with olopatadine hydrochloride ophthalmic solution 0.2%

    Reporting group title
    PATANOL
    Reporting group description
    		 All subjects treated with olopatadine hydrochloride ophthalmic solution 0.1%

    Serious adverse events
    		 PATADAY PATANOL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 126 (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
    		 PATADAY PATANOL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 126 (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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