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    Clinical Trial Results:
    Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients

    Summary
    EudraCT number
    		 2017-003841-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    04 Jul 2011

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

    Trial information

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    Trial identification
    Sponsor protocol code
    JPN-P-2010-1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01109485
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alcon Research, Japan
    Sponsor organisation address
    6201 S. Freeway, Fort Worth, Texas, United States, 76134
    Public contact
    Ophthalmology Unit, Novartis Pharmaceuticals, +44 01276 6673 3391, dennis.wong@novartis.com
    Scientific contact
    Ophthalmology Unit, Novartis Pharmaceuticals, +44 01276 6673 3391, 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
    04 Jul 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 Jul 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Jul 2011
    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 safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children 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
    27 Feb 2010
    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
    Japan: 70
    Worldwide total number of subjects
    70
    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)
    51
    Adolescents (12-17 years)
    19
    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
    		 Subjects were recruited from 2 study centers located in Japan.

    Pre-assignment
    Screening details
    		 This reporting group includes all enrolled and randomized subjects (70).

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Olopatadine
    Arm description
    		 Olopatadine hydrochloride ophthalmic solution 0.1%, 1-2 drops q.i.d. (4 times per day:, morning, afternoon, evening, and at bedtime) for 4 weeks
    Arm type
    		 Experimental

    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
    Ophthalmic use
    Dosage and administration details
    Olopatadine hydrochloride ophthalmic solution 0.1%, 1-2 drops QID (morning, afternoon, evening, and at bedtime) for 4 weeks

    Number of subjects in period 1
    		Olopatadine
    Started
    70
    Completed
    42
    Not completed
    28
         Reason not given
    27
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Olopatadine
    Reporting group description
    		 Olopatadine hydrochloride ophthalmic solution 0.1%, 1-2 drops q.i.d. (4 times per day:, morning, afternoon, evening, and at bedtime) for 4 weeks

    Reporting group values
    		 Olopatadine Total
    Number of subjects
    		 70 70
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 51 51
        Adolescents (12-17 years)
    		 19 19
    Gender categorical
    Units: Subjects
        Female
    		 37 37
        Male
    		 33 33

    End points

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    End points reporting groups
    Reporting group title
    Olopatadine
    Reporting group description
    		 Olopatadine hydrochloride ophthalmic solution 0.1%, 1-2 drops q.i.d. (4 times per day:, morning, afternoon, evening, and at bedtime) for 4 weeks

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Efficacy Analysis Set at Baseline

    Subject analysis set title
    Week 1
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Efficacy Analysis Set at Week 1

    Subject analysis set title
    Week 2
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Efficacy Analysis Set at Week 2

    Subject analysis set title
    Week 4
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Efficacy Analysis Set at Week 4

    Primary: Number of Adverse Drug Reactions (ADR)

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    End point title
    		 Number of Adverse Drug Reactions (ADR) [1]
    End point description
    An adverse event (AE) is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product (IP), whether or not considered related to the investigational product. Of the AEs reported, all cases judged as having a possible causal relationship to the investigational product (IP) qualified as ADRs. This analysis population includes all subjects exposed to IP (Safety Analysis Set).
    End point type
    Primary
    End point timeframe
    Up through Week 4
    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 analysis was planned or conducted for this primary endpoint.
    End point values
    		 Olopatadine
    Number of subjects analysed
    70
    Units: number
    0
    No statistical analyses for this end point

    Primary: Severity Score of Subjective Symptoms by Visit

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    End point title
    		 Severity Score of Subjective Symptoms by Visit [2]
    End point description
    The severity score of subjective symptoms (eye pruritus, foreign body sensation in eyes, eye pain, lacrimation, photophobia, and eye discharge) was assessed by interviewing subjects at scheduled visits. Each symptom was rated on a scale of 0-3, where 0=None, 1=Mild, 2=Moderate, and 3=Severe. This analysis population includes all treated subjects with a follow-up period of four weeks (Efficacy Analysis Set).
    End point type
    Primary
    End point timeframe
    Baseline, Week 1, Week 2, Week 4
    Notes
    [2] - 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: This was a one-arm descriptive study; no hypothesis testing was performed. Descriptive statistics were provided.
    End point values
    		 Baseline Week 1 Week 2 Week 4
    Number of subjects analysed
    42 [3]
    38 [4]
    26 [5]
    41 [6]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Eye Pruritus
    1.64 ± 0.94
    1.04 ± 0.9
    0.9 ± 0.87
    0.7 ± 0.9
        Eye Discharge
    0.61 ± 0.64
    0.25 ± 0.52
    0.35 ± 0.71
    0.17 ± 0.54
        Lacrimation
    0.52 ± 0.74
    0.34 ± 0.66
    0.15 ± 0.42
    0.11 ± 0.39
        Photophobia
    0.32 ± 0.72
    0.16 ± 0.44
    0.17 ± 0.47
    0.2 ± 0.46
        Foreign Body Sensation in Eyes
    0.33 ± 0.61
    0.24 ± 0.54
    0.21 ± 0.46
    0.22 ± 0.57
        Eye Pain
    0.35 ± 0.62
    0.2 ± 0.5
    0.17 ± 0.47
    0.13 ± 0.44
    Notes
    [3] - Efficacy Analysis Set, n=42, 42, 42, 41, 42, 41
    [4] - Efficacy Analysis Set, n=38, 38, 38, 37, 38, 37
    [5] - Efficacy Analysis Set
    [6] - Efficacy Analysis Set, n=41, 41, 41, 42, 41, 41
    No statistical analyses for this end point

    Primary: Severity Score of Objective Symptoms by Visit

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    End point title
    		 Severity Score of Objective Symptoms by Visit [7]
    End point description
    The severity score of objective symptoms (conjunctival hyperaemia, conjunctival swelling, conjunctival follicles, conjunctival papillae, conjunctival oedema and corneal complications) was assessed by interviewing subjects at scheduled visits. Each symptom was rated on a scale of 0-3, where 0=None, 1=Mild, 2=Moderate, and 3=Severe. Efficacy Analysis Set.
    End point type
    Primary
    End point timeframe
    Baseline, Week 1, Week 2, Week 4
    Notes
    [7] - 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: This was a one-arm descriptive study; no hypothesis testing was performed. Descriptive statistics were provided.
    End point values
    		 Baseline Week 1 Week 2 Week 4
    Number of subjects analysed
    42 [8]
    38 [9]
    26 [10]
    42 [11]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Palpebral Conjunctiva: Hyperaemia
    1.43 ± 0.61
    0.72 ± 0.65
    0.71 ± 0.46
    0.67 ± 0.67
        Palpebral Conjunctiva: Swelling
    1.18 ± 0.73
    0.47 ± 0.62
    0.44 ± 0.57
    0.27 ± 0.5
        Palpebral Conjunctiva: Follicle
    0.65 ± 0.61
    0.41 ± 0.62
    0.37 ± 0.53
    0.26 ± 0.52
        Palpebral Conjunctiva: Papillae
    1.6 ± 0.73
    1.04 ± 0.62
    0.94 ± 0.7
    0.73 ± 0.68
        Palpebral Conjunctiva: Giant Papillae
    0.21 ± 0.52
    0.01 ± 0.12
    0.12 ± 0.51
    0.06 ± 0.28
        Bulbar Conjunctiva: Hyperaemia
    0.83 ± 0.71
    0.32 ± 0.55
    0.35 ± 0.56
    0.26 ± 0.49
        Bulbar Conjunctiva: Oedema
    0.6 ± 0.71
    0.21 ± 0.5
    0.15 ± 0.46
    0.13 ± 0.4
        Limbus: Trantas' Dots
    0.1 ± 0.4
    0.07 ± 0.3
    0.12 ± 0.58
    0.05 ± 0.31
        Limbus: Swelling
    0.07 ± 0.26
    0.04 ± 0.2
    0.12 ± 0.58
    0.05 ± 0.31
        Cornea: Epithelium Disorder
    0.05 ± 0.21
    0.03 ± 0.16
    0.08 ± 0.27
    0.02 ± 0.15
    Notes
    [8] - Efficacy Analysis Set
    [9] - Efficacy Analysis Set, n=38, 38, 38, 38, 38, 38, 38, 38, 38, 36
    [10] - Efficacy Analysis Set
    [11] - Efficacy Analysis Set
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Olopatadine
    Reporting group description
    		 Olopatadine hydrochloride ophthalmic solution 0.1%, 1-2 drops q.i.d. (4 times per day:, morning, afternoon, evening, and at bedtime) for 4 weeks

    Serious adverse events
    		 Olopatadine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 70 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Olopatadine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 70 (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 were reported in this study.

    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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