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Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
AL-4943A ophthalmic solution
Olopatadine hydrochloride ophthalmic solution, 0.2%
Olopatadine hydrochloride ophthalmic solution, 0.1%
AL-4943A ophthalmic solution vehicle
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergic conjunctivitis, Olopatadine HCl solution, Conjunctival Allergen Challenge, Itching eyes, Ocular allergies, PATADAY, PATANOL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
  • Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
  • Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.
  • History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
  • Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
  • Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.
  • Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
  • Presence of an ocular condition that may affect the study outcomes.
  • History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1.
  • Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4.
  • History of anaphylactic reaction to any allergens used in this study.
  • Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases.
  • Use of any disallowed medication without protocol-specified washout period prior to Visit 1, or during the study.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    AL-4943A

    PATADAY

    PATANOL

    Vehicle

    Arm Description

    AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14

    Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14

    Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14

    AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14

    Outcomes

    Primary Outcome Measures

    Mean Ocular Itching at Onset of Action
    A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.
    Mean Ocular Itching at 24 Hours Duration of Action
    A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.

    Secondary Outcome Measures

    Mean Conjunctival Redness at Onset of Action
    A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
    Mean Conjunctival Redness at 24 Hours Duration of Action
    A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
    Mean Total Redness at Onset of Action
    A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.
    Mean Total Redness at 24 Hours Duration of Action
    A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.
    Proportion of Ocular Itching Responders at Onset of Action
    A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.
    Proportion of Itch Responders at 24 Hours Duration of Action
    A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.

    Full Information

    First Posted
    December 4, 2012
    Last Updated
    July 18, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01743027
    Brief Title
    Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis
    Official Title
    Phase 3, Efficacy and Safety Study of AL-4943A Ophthalmic Solution, 0.77% in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    July 2013 (Actual)
    Study Completion Date
    July 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.
    Detailed Description
    Enrolled participants will be tested for the presence of common allergies using the Conjunctival Allergen Challenge (CAC) model. Drops of increasing concentration of a solubilized allergen will be instilled in both eyes until a positive reaction occurred. The test will be repeated to confirm the allergic reaction. Participants with confirmed reactions will be administered the test article (Day 0) and undergo a CAC 24 hours post-instillation (Day 1). On Day 14, participants will be administered the test article and undergo an additional CAC.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Conjunctivitis
    Keywords
    Allergic conjunctivitis, Olopatadine HCl solution, Conjunctival Allergen Challenge, Itching eyes, Ocular allergies, PATADAY, PATANOL

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    902 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AL-4943A
    Arm Type
    Experimental
    Arm Description
    AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
    Arm Title
    PATADAY
    Arm Type
    Active Comparator
    Arm Description
    Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
    Arm Title
    PATANOL
    Arm Type
    Active Comparator
    Arm Description
    Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
    Intervention Type
    Drug
    Intervention Name(s)
    AL-4943A ophthalmic solution
    Intervention Type
    Drug
    Intervention Name(s)
    Olopatadine hydrochloride ophthalmic solution, 0.2%
    Other Intervention Name(s)
    PATADAY®
    Intervention Type
    Drug
    Intervention Name(s)
    Olopatadine hydrochloride ophthalmic solution, 0.1%
    Other Intervention Name(s)
    PATANOL®
    Intervention Type
    Drug
    Intervention Name(s)
    AL-4943A ophthalmic solution vehicle
    Primary Outcome Measure Information:
    Title
    Mean Ocular Itching at Onset of Action
    Description
    A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.
    Time Frame
    Day 14 (3, 5, and 7 minutes post-CAC)
    Title
    Mean Ocular Itching at 24 Hours Duration of Action
    Description
    A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.
    Time Frame
    Day 1 (3, 5, and 7 minutes post-CAC)
    Secondary Outcome Measure Information:
    Title
    Mean Conjunctival Redness at Onset of Action
    Description
    A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
    Time Frame
    Day 14 (7, 15, and 20 minutes post-CAC)
    Title
    Mean Conjunctival Redness at 24 Hours Duration of Action
    Description
    A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
    Time Frame
    Day 1 (7, 15, and 20 minutes post-CAC)
    Title
    Mean Total Redness at Onset of Action
    Description
    A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.
    Time Frame
    Day 14 (7, 15, and 20 minutes post-CAC)
    Title
    Mean Total Redness at 24 Hours Duration of Action
    Description
    A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.
    Time Frame
    Day 1 (7, 15, and 20 minutes post-CAC)
    Title
    Proportion of Ocular Itching Responders at Onset of Action
    Description
    A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.
    Time Frame
    Day 14
    Title
    Proportion of Itch Responders at 24 Hours Duration of Action
    Description
    A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.
    Time Frame
    Day 1

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions. Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period. Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1. History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1. Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method). Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response. Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes. Presence of an ocular condition that may affect the study outcomes. History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1. Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4. History of anaphylactic reaction to any allergens used in this study. Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases. Use of any disallowed medication without protocol-specified washout period prior to Visit 1, or during the study. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abhijit Narvekar, MS, MBBS
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27466061
    Citation
    Carr W, Schaeffer J, Donnenfeld E. Treating allergic conjunctivitis: A once-daily medication that provides 24-hour symptom relief. Allergy Rhinol (Providence). 2016 Jan;7(2):107-14. doi: 10.2500/ar.2016.7.0158. Epub 2016 Jul 26.
    Results Reference
    derived
    PubMed Identifier
    26266427
    Citation
    McLaurin E, Narvekar A, Gomes P, Adewale A, Torkildsen G. Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model. Cornea. 2015 Oct;34(10):1245-51. doi: 10.1097/ICO.0000000000000562.
    Results Reference
    derived

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    Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis

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