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    Clinical Trial Results:
    An Open-label, Long-term Study, with AL-4943A Ophthalmic Solution, 0.2% in Patients with Allergic Conjunctivitis

    Summary
    EudraCT number
    		 2017-003953-41
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    23 May 2010

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

    Trial information

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    Trial identification
    Sponsor protocol code
    C-09-050
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01037179
    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 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
    23 May 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 May 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    23 May 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study was to assess safety and efficacy of long-term use of AL-4943A Ophthalmic Solution, 0.2% in patients 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
    17 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: 110
    Worldwide total number of subjects
    110
    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)
    0
    Adolescents (12-17 years)
    10
    Adults (18-64 years)
    100
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were recruited from 1 study center located in Japan.

    Pre-assignment
    Screening details
    		 This reporting group includes all enrolled and treated subjects.

    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
    		 AL-4943A 0.2%
    Arm description
    		 AL-4943A 0.2% ophthalmic solution, 2 drops in each eye, twice daily (morning and evening) for 10 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    AL-4943A 0.2% ophthalmic solution
    Investigational medicinal product code
    Other name
    Pataday™
    Pharmaceutical forms
    Eye drops, solution
    Routes of administration
    Ophthalmic use
    Dosage and administration details
    Two drops in each eye, twice daily (morning and evening) for 10 weeks

    Number of subjects in period 1
    		AL-4943A 0.2%
    Started
    110
    Completed
    109
    Not completed
    1
         Subject withdrawal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AL-4943A 0.2%
    Reporting group description
    		 AL-4943A 0.2% ophthalmic solution, 2 drops in each eye, twice daily (morning and evening) for 10 weeks

    Reporting group values
    		 AL-4943A 0.2% Total
    Number of subjects
    		 110 110
    Age categorical
    Units: Subjects
    Age continuous
    This analysis population includes all subjects who received study medication and completed at least one on-therapy study visit (Intent-to-Treat Analysis Set).
    Units: years
        arithmetic mean (standard deviation)
    		 36.7 ( 10.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 66 66
        Male
    		 44 44
    Itching Score
    Ocular itching was assessed by the subject and graded on a 6-unit scale, where 0=”did not occur” and 5=”virtually all the time over the past three days”. Intent-to-Treat Analysis Set.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 4.3 ( 0.6 ) -
    Total Hyperemia Score
    Ocular hyperemia (visible eye redness) was assessed by the investigator. Total hyperemia score was defined as the sum of palpebral and bulbar conjunctival hyperemia scores. Each hyperemia was measured on 6-unit scale, where 0=none and 5=severe redness. Intent-to-Treat Analysis Set.
    Units: units on a scale
        arithmetic mean (standard deviation)
    		 4.0 ( 1.2 ) -

    End points

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    End points reporting groups
    Reporting group title
    AL-4943A 0.2%
    Reporting group description
    		 AL-4943A 0.2% ophthalmic solution, 2 drops in each eye, twice daily (morning and evening) for 10 weeks

    Subject analysis set title
    Baseline
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-Treat Analysis Set at Baseline

    Subject analysis set title
    Week 2
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-Treat Analysis Set at Week 2

    Subject analysis set title
    Week 4
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-Treat Analysis Set at Week 4

    Subject analysis set title
    Week 6
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-Treat Analysis Set at Week 6

    Subject analysis set title
    Week 8
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-Treat Analysis Set at Week 8

    Subject analysis set title
    Week 10
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Intent-to-Treat Analysis Set at Week 10

    Primary: Mean Change from Baseline (BL) in Itching Score by Visit

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    End point title
    		 Mean Change from Baseline (BL) in Itching Score by Visit [1]
    End point description
    Ocular itching was assessed by the subject and graded on a 6-unit scale, where 0=”did not occur” and 5=”virtually all the time over the past three days”. Average scores from the subject’s two eyes were used. A more negative change indicates improvement. Intent-To-Treat, with missing data imputed using Last Observation Carried Forward (LOCF).
    End point type
    Primary
    End point timeframe
    Baseline, Week 2, Week 4, Week 6, Week 8, Week 10
    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: This was a one-arm descriptive study; no hypothesis testing was performed. Descriptive statistics were provided. Comparisons for each week vs baseline were presented.
    End point values
    		 AL-4943A 0.2%
    Number of subjects analysed
    110
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 2
    -1.2 ( 1.2 )
        Week 4
    -1.5 ( 1.4 )
        Week 6
    -1.8 ( 1.5 )
        Week 8
    -2.2 ( 1.6 )
        Week 10
    -2.4 ( 1.7 )
    No statistical analyses for this end point

    Primary: Mean Change from BL in Total Hyperemia Score by Visit

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    End point title
    		 Mean Change from BL in Total Hyperemia Score by Visit [2]
    End point description
    Ocular hyperemia (visible eye redness) was assessed by the investigator. Total hyperemia score was defined as the sum of palpebral and bulbar conjunctival hyperemia scores. Each hyperemia was measured on 6-unit scale, where 0=none and 5=severe redness. Average scores from the subject's both eyes were used. A more negative change indicates improvement. Intent-to-Treat, with missing values imputed using LOCF.
    End point type
    Primary
    End point timeframe
    Baseline, Week 2, Week 4, Week 6, Week 8, Week 10
    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
    		 AL-4943A 0.2%
    Number of subjects analysed
    110
    Units: units on a scale
    arithmetic mean (standard deviation)
        Week 2
    -0.9 ( 1.2 )
        Week 4
    -1.5 ( 1.3 )
        Week 6
    -2.1 ( 1.3 )
        Week 8
    -2.7 ( 1.3 )
        Week 10
    -3.2 ( 1.3 )
    No statistical analyses for this end point

    Secondary: Subjective Symptoms (except ocular itching)

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    End point title
    		 Subjective Symptoms (except ocular itching)
    End point description
    Subjective symptoms were measured on 4-unit scale (Photophobia: 0=Not glaring to 3=Too glaring to open the eyes in a light place; Lacrimation: 0=Does not weigh on mind to 3=Tearful so that tears flow down the cheek; Eye Discharge: 0=Does not weigh on mind to 3=So much as to glue the eyelids shut on awaking in the morning; Foreign Body Sensation: 0=Does not weigh on mind to 3=Always feels gritty so that the eyes cannot be kept open; and Eye Pain: 0=Painless to 3=Too painful to open the eyes). Average scores from the subject's both eyes were used. Intent-To-Treat, with missing data imputed using LOCF. Descriptive statistics are presented.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, Week 4, Week 6, Week 8, Week 10
    End point values
    		 Baseline Week 2 Week 4 Week 6 Week 8 Week 10
    Number of subjects analysed
    110
    110
    110
    110
    110
    110
    Units: units on a scale
    arithmetic mean (standard deviation)
        Photophobia
    0.2 ( 0.5 )
    0.1 ( 0.3 )
    0.1 ( 0.3 )
    0.1 ( 0.3 )
    0.1 ( 0.3 )
    0.0 ( 0.2 )
        Lacrimation Score
    0.8 ( 0.8 )
    0.5 ( 0.7 )
    0.4 ( 0.6 )
    0.3 ( 0.5 )
    0.2 ( 0.5 )
    0.1 ( 0.4 )
        Eye Discharge Score
    0.6 ( 0.8 )
    0.5 ( 0.6 )
    0.3 ( 0.5 )
    0.2 ( 0.5 )
    0.2 ( 0.5 )
    0.1 ( 0.4 )
        Foreign Body Sensation Score
    0.8 ( 0.6 )
    0.4 ( 0.6 )
    0.3 ( 0.5 )
    0.2 ( 0.5 )
    0.2 ( 0.4 )
    0.1 ( 0.3 )
        Eye Pain Score
    0.2 ( 0.4 )
    0.1 ( 0.4 )
    0.1 ( 0.3 )
    0.1 ( 0.2 )
    0.0 ( 0.2 )
    0.0 ( 0.2 )
    No statistical analyses for this end point

    Secondary: Objective Findings

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    End point title
    		 Objective Findings
    End point description
    Palpebral conjunctiva hyperemia and bulbar conjunctiva hyperemia were measured on a 6-unit scale, where 0=none/minimum redness and 5=maximum redness. Other objective findings were measured on a 4-unit scale (Swelling: 0=none to 3=Diffuse swelling of eyelid with opacity; Follicles: 0=none to 3=20 or more follicles, Papilla: 0=none to 3=0.6 or more of diameter; Megalopapilla: 0=none to 3=Papilla of upper palpebral conjunctiva is bulging in the range of 1/2 or more; Edema: 0=none to 3=Alveolar edema; Trantas' dots: 0=none to 3=9 dots or more; Circumference Swelling: 0=none to 3=Range is more than 2/3 of circumference; Corneal Epithelium: 0=none to 3=Shield ulcer or epithelial erosion). Average scores from the individual's both eyes were used. Intent-To-Treat, with missing data imputed using LOCF. Descriptive statistics are presented.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, Week 4, Week 6, Week 8, Week 10
    End point values
    		 Baseline Week 2 Week 4 Week 6 Week 8 Week 10
    Number of subjects analysed
    110
    110
    110
    110
    110
    110
    Units: units on a scale
    arithmetic mean (standard deviation)
        Palpebral conjunctiva hyperemia
    2.4 ( 0.6 )
    1.8 ( 0.7 )
    1.6 ( 0.7 )
    1.3 ( 0.8 )
    0.9 ( 0.7 )
    0.6 ( 0.7 )
        Swelling
    1.2 ( 0.5 )
    1.1 ( 0.6 )
    1.0 ( 0.5 )
    0.9 ( 0.6 )
    0.6 ( 0.5 )
    0.5 ( 0.5 )
        Follicles
    0.9 ( 0.7 )
    1.0 ( 0.9 )
    0.9 ( 0.7 )
    0.7 ( 0.6 )
    0.6 ( 0.6 )
    0.4 ( 0.5 )
        Papilla
    0.6 ( 0.7 )
    0.4 ( 0.5 )
    0.4 ( 0.5 )
    0.3 ( 0.4 )
    0.3 ( 0.4 )
    0.2 ( 0.4 )
        Megalopapilla
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
        Bulbar conjunctiva hyperemia
    1.6 ( 0.8 )
    1.2 ( 0.6 )
    0.9 ( 0.6 )
    0.6 ( 0.7 )
    0.4 ( 0.5 )
    0.2 ( 0.4 )
        Edema
    0.9 ( 0.6 )
    0.7 ( 0.5 )
    0.7 ( 0.5 )
    0.6 ( 0.5 )
    0.4 ( 0.5 )
    0.2 ( 0.4 )
        Trantas’ dots
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
        Circumference swelling
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
        Corneal Epithelium
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    0.0 ( 0.0 )
    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. This analysis population includes all subjects who received study medication (Safety Analysis Set).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA/J
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    AL-4943A 0.2%
    Reporting group description
    		 AL-4943A 0.2% ophthalmic solution, 2 drops in each eye, twice daily (morning and evening) for 10 weeks

    Serious adverse events
    		 AL-4943A 0.2%
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 110 (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
    		 AL-4943A 0.2%
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    74 / 110 (67.27%)
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    74 / 110 (67.27%)
         occurrences all number
    98

    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
    For support, Contact us.
    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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