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    Clinical Trial Results:
    Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients

    Summary
    EudraCT number
    		 2017-003856-22
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    24 Nov 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Feb 2018
    First version publication date
    02 Feb 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C-07-01
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00578929
    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
    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
    24 Nov 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Nov 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Nov 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to compare Olopatadine Hydrochloride (HCl) Nasal Spray 0.6% and Olopatadine HCl Nasal Spray Vehicle when given twice daily (BID) for the treatment of Seasonal Allergic Rhinitis (SAR) for a 2-week period.
    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
    28 Sep 2007
    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: 1188
    Worldwide total number of subjects
    1188
    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)
    1188
    Adolescents (12-17 years)
    0
    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 173 study centers in the United States.

    Pre-assignment
    Screening details
    		 A total of 2388 subjects were screened for possible study participation and given Olopatadine HCl Nasal Spray Vehicle as run-in treatment. Of these, 1200 subjects were screen failures and not enrolled into the study. The remaining 1188 subjects were enrolled into the randomized treatment period. This reporting group includes all treated subjects.

    Period 1
    Period 1 title
    Treatment (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
    		 Olo 0.6% 1 Spray
    Arm description
    		 Olopatadine HCl Nasal Spray 0.6%, 1 spray per nostril BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olopatadine HCl Nasal Spray 0.6%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Olopatadine HCl Nasal Spray 0.6%, 1 spray per nostril BID

    Arm title
    		 Olo 0.6% 2 Sprays
    Arm description
    		 Olopatadine HCl Nasal Spray 0.6%, 2 sprays per nostril BID
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olopatadine HCl Nasal Spray 0.6%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Olopatadine HCl Nasal Spray 0.6%, 2 sprays per nostril BID

    Arm title
    		 Veh 1 Spray
    Arm description
    		 Olopatadine HCl Nasal Spray Vehicle, 1 spray per nostril BID
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Olopatadine HCl Nasal Spray Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Olopatadine HCl Nasal Spray Vehicle, 1 or 2 sprays per nostril BID

    Arm title
    		 Veh 2 sprays
    Arm description
    		 Olopatadine HCl Nasal Spray Vehicle, 2 sprays per nostril BID
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Olopatadine HCl Nasal Spray Vehicle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Olopatadine HCl Nasal Spray Vehicle, 1 or 2 sprays per nostril BID

    Number of subjects in period 1
    		Olo 0.6% 1 Spray Olo 0.6% 2 Sprays Veh 1 Spray Veh 2 sprays
    Started
    298
    296
    297
    297
    Completed
    281
    288
    283
    283
    Not completed
    17
    8
    14
    14
         Reason not given
    3
    -
    -
    1
         Adverse event, non-fatal
    7
    5
    4
    4
         Protocol violation
    1
    -
    3
    -
         Treatment Failure
    3
    2
    4
    8
         Decision unrelated to an AE
    1
    -
    2
    1
         Lost to follow-up
    2
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Olo 0.6% 1 Spray
    Reporting group description
    		 Olopatadine HCl Nasal Spray 0.6%, 1 spray per nostril BID

    Reporting group title
    Olo 0.6% 2 Sprays
    Reporting group description
    		 Olopatadine HCl Nasal Spray 0.6%, 2 sprays per nostril BID

    Reporting group title
    Veh 1 Spray
    Reporting group description
    		 Olopatadine HCl Nasal Spray Vehicle, 1 spray per nostril BID

    Reporting group title
    Veh 2 sprays
    Reporting group description
    		 Olopatadine HCl Nasal Spray Vehicle, 2 sprays per nostril BID

    Reporting group values
    		 Olo 0.6% 1 Spray Olo 0.6% 2 Sprays Veh 1 Spray Veh 2 sprays Total
    Number of subjects
    		 298 296 297 297 1188
    Age categorical
    Units: Subjects
        6 to 8 years
    		 121 121 121 122 485
        9 to 11 years
    		 177 175 176 175 703
    Gender categorical
    Units: Subjects
        Female
    		 130 122 125 124 501
        Male
    		 168 174 172 173 687
    Total Reflective Nasal Symptom Score (rTNSS)
    Nasal symptoms scores (runny nose, stuffy nose, itchy nose, and sneezing) were evaluated twice daily while on study therapy via subject diary and rated on a 4-unit scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Baseline rTNSS was the average of the AM and PM reflective severity scores for the sum of the individual severity scores averaged across 3 qualifying diary days.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 8.99 ± 1.757 9.16 ± 1.598 9.11 ± 1.686 8.85 ± 1.785 -
    Total Reflective Ocular Symptom Score (TOSS)
    Ocular symptoms (itchy eyes and watery eyes) were evaluated twice daily while on study therapy via a subject diary and rated on a 4-unit scale, where 0=none, 1=mild, 2=moderate, and 3=severe. Baseline reflective TOSS was the average of the AM and PM reflective severity scores for the sum of the individual severity scores averaged across 3 qualifying diary days.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 3.46 ± 1.565 3.59 ± 1.489 3.53 ± 1.56 3.29 ± 1.662 -

    End points

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    End points reporting groups
    Reporting group title
    Olo 0.6% 1 Spray
    Reporting group description
    		 Olopatadine HCl Nasal Spray 0.6%, 1 spray per nostril BID

    Reporting group title
    Olo 0.6% 2 Sprays
    Reporting group description
    		 Olopatadine HCl Nasal Spray 0.6%, 2 sprays per nostril BID

    Reporting group title
    Veh 1 Spray
    Reporting group description
    		 Olopatadine HCl Nasal Spray Vehicle, 1 spray per nostril BID

    Reporting group title
    Veh 2 sprays
    Reporting group description
    		 Olopatadine HCl Nasal Spray Vehicle, 2 sprays per nostril BID

    Subject analysis set title
    Olo 0.6% 1 spray
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    This analysis population includes all subjects who received study medication and had at least 1 on-therapy visit (Intent-to-Treat (ITT) Analysis Set).

    Subject analysis set title
    Veh 1 spray
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intent-to-Treat, with non-missing data at both visits and nonzero baseline data

    Subject analysis set title
    Olo 0.6% 2 sprays
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intent-to-Treat, with non-missing data at both visits and nonzero baseline data

    Subject analysis set title
    Veh 2 sprays
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intent-to-Treat, with non-missing data at both visits and nonzero baseline data

    Subject analysis set title
    Olo 0.6% 1 spray
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intent-to-treat, with non-missing data at both visits and nonzero baseline data

    Subject analysis set title
    Veh 1 spray
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intent-to-treat, with non-missing data at both visits and nonzero baseline data

    Subject analysis set title
    Olo 0.6% 2 sprays
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intent-to-Treat, with non-missing data at both visits and nonzero baseline data

    Subject analysis set title
    Veh 2 sprays
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Intent-to-Treat, with non-missing data at both visits and nonzero baseline data

    Primary: Percent Change from Baseline in rTNSS

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    End point title
    		 Percent Change from Baseline in rTNSS
    End point description
    The rTNSS was defined as the average of the AM and PM reflective (how the subject felt for the last 12 hours) severity scores for the sum of assessments of runny nose, stuffy nose, itchy nose, and sneezing, averaged across the first 14 complete days of the randomized treatment phase. Symptoms were evaluated twice daily while on study therapy via a subject telephone diary and rated on a 4-unit scale, where 0=none, 1=mild, 2=moderate, and 3=severe. A more negative change number indicates improvement, namely lessening of the symptom.
    End point type
    Primary
    End point timeframe
    Baseline, up through first 14 complete days of treatment
    End point values
    		 Olo 0.6% 1 spray Veh 1 spray Olo 0.6% 2 sprays Veh 2 sprays
    Number of subjects analysed
    294
    294
    293
    293
    Units: units on a scale
        arithmetic mean (standard deviation)
    -24.69 ± 25.475
    -17.91 ± 24.125
    -26.46 ± 24.897
    -20.82 ± 24.394
    Statistical analysis title
    		 Percent Change from Baseline in rTNSS
    Comparison groups
    Olo 0.6% 2 sprays v Veh 2 sprays
    Number of subjects included in analysis
    586
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.012
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Percent Change from Baseline in rTNSS
    Comparison groups
    Olo 0.6% 1 spray v Veh 1 spray
    Number of subjects included in analysis
    588
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0007
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Percent Change from Baseline in rTOSS

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    End point title
    		 Percent Change from Baseline in rTOSS
    End point description
    The rTOSS was defined as the average of the AM and PM reflective severity scores for the sum of the assessments of ocular symptoms (itchy and watery eyes), averaged across 14 days. Symptoms were evaluated twice daily while on study therapy via a subject telephone diary and rated on a 4-unit scale, where 0=none, 1=mild, 2=moderate, and 3=severe. A more negative change number indicates improvement, namely lessening of the symptom.
    End point type
    Secondary
    End point timeframe
    Baseline, up through first 14 complete days of treatment
    End point values
    		 Olo 0.6% 1 spray Veh 1 spray Olo 0.6% 2 sprays Veh 2 sprays
    Number of subjects analysed
    287
    288
    289
    283
    Units: units on a scale
        arithmetic mean (standard deviation)
    -24.45 ± 59.073
    -6.06 ± 108.653
    -26.34 ± 41.552
    -8.20 ± 71.537
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    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.
    Adverse event reporting additional description
    Only total subjects affected by non-serious AEs that occur at >5% are reported.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Olo 0.6% 1 Spray
    Reporting group description
    		 Olopatadine HCl Nasal Spray 0.6%, 1 spray per nostril BID

    Reporting group title
    Olo 0.6% 2 Sprays
    Reporting group description
    		 Olopatadine HCl Nasal Spray 0.6%, 2 sprays per nostril BID

    Reporting group title
    Veh 1 Spray
    Reporting group description
    		 Olopatadine HCl Nasal Spray Vehicle, 1 spray per nostril BID

    Reporting group title
    Veh 2 sprays
    Reporting group description
    		 Olopatadine HCl Nasal Spray Vehicle, 2 sprays per nostril BID

    Serious adverse events
    		 Olo 0.6% 1 Spray Olo 0.6% 2 Sprays Veh 1 Spray Veh 2 sprays
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 298 (0.00%)
    0 / 296 (0.00%)
    0 / 297 (0.00%)
    0 / 297 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Olo 0.6% 1 Spray Olo 0.6% 2 Sprays Veh 1 Spray Veh 2 sprays
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    29 / 298 (9.73%)
    26 / 296 (8.78%)
    21 / 297 (7.07%)
    30 / 297 (10.10%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    13 / 298 (4.36%)
    9 / 296 (3.04%)
    11 / 297 (3.70%)
    16 / 297 (5.39%)
         occurrences all number
    16
    9
    11
    16
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    17 / 298 (5.70%)
    18 / 296 (6.08%)
    11 / 297 (3.70%)
    16 / 297 (5.39%)
         occurrences all number
    19
    22
    15
    22

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jul 2008
    Statistical analysis section revised to incorporate an analysis of covariance with randomization stratification factor and baseline TNSS as covariates, as instructed by Health Authority.

    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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