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Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
AL-4943A ophthalmic solution
AL-4943A vehicle
Olopatadine hydrochloride ophthalmic solution, 0.2%
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, Ocular Allergy

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.
  • Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of Visit 1.
  • History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
  • Positive bilateral CAC response at Visit 1 and Visit 2.
  • 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 requiring frequent use (> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
  • Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
  • Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of Visit 1.
  • Presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the Investigator is likely to advance/worsen during the time course of the study.
  • Any contraindications or hypersensitivities to the use of the study medication or their components.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    Active Comparator

    Arm Label

    AL-4943A

    Vehicle

    Pataday

    Arm Description

    AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days

    AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days

    Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days

    Outcomes

    Primary Outcome Measures

    Mean Ocular Itching at Onset of Action
    A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
    Mean Ocular Itching at 16 Hours Duration of Action
    A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 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 instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
    Mean Conjunctival Redness at 16 Hours Duration of Action
    A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score 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. Total redness (0-12) is defined as the sum of ciliary redness (0-4 scale, from 0=none to 4=extremely severe), conjunctival redness (0-4 scale, from 0=none to 4=extremely severe), and episcleral redness (0-4 scale, from 0=none to 4=extremely severe). Average of total redness 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. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching 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. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.

    Full Information

    First Posted
    November 22, 2011
    Last Updated
    May 28, 2013
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01479374
    Brief Title
    Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model
    Official Title
    A Multi-Center, Randomized, Double-Masked, Vehicle and Active Controlled, Parallel-Group 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
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    March 2012 (Actual)
    Study Completion Date
    March 2012 (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 was to assess the safety and efficacy of AL-4943A ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.
    Detailed Description
    This study consisted of 5 Visits. Eligible patients underwent allergy testing using the Conjunctival Allergen Challenge (CAC) model, which reproduces the signs and symptoms of Seasonal Allergic Conjunctivitis by replicating the natural disease process. Patients demonstrating a positive reaction to the CAC at Visit 1 (screening) and Visit 2 (confirmatory) were randomized to treatment at Visit 3 (Day 0). The test article was instilled at Visit 3, with treatment efficacy CAC performed at 24 hours duration of action. The test article was instilled again at Visit 4 (Day 14), with treatment efficacy CAC performed at 16 hours duration of action. The test article was instilled a final time at Visit 5 (Day 21), with treatment efficacy performed at onset of action.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Conjunctivitis
    Keywords
    Allergic Conjunctivitis, Ocular Allergy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    397 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AL-4943A
    Arm Type
    Experimental
    Arm Description
    AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
    Arm Title
    Vehicle
    Arm Type
    Placebo Comparator
    Arm Description
    AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
    Arm Title
    Pataday
    Arm Type
    Active Comparator
    Arm Description
    Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
    Intervention Type
    Drug
    Intervention Name(s)
    AL-4943A ophthalmic solution
    Intervention Type
    Drug
    Intervention Name(s)
    AL-4943A vehicle
    Intervention Description
    Inactive ingredients used as placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Olopatadine hydrochloride ophthalmic solution, 0.2%
    Other Intervention Name(s)
    PATADAY®
    Primary Outcome Measure Information:
    Title
    Mean Ocular Itching at Onset of Action
    Description
    A treatment efficacy CAC was performed 27 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
    Time Frame
    3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment
    Title
    Mean Ocular Itching at 16 Hours Duration of Action
    Description
    A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
    Time Frame
    3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment
    Secondary Outcome Measure Information:
    Title
    Mean Conjunctival Redness at Onset of Action
    Description
    A treatment efficacy CAC was performed 27 minutes after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
    Time Frame
    7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment
    Title
    Mean Conjunctival Redness at 16 Hours Duration of Action
    Description
    A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
    Time Frame
    7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment
    Title
    Mean Total Redness at 24 Hours Duration of Action
    Description
    A treatment efficacy CAC was performed 24 hours after drop instillation. Total redness (0-12) is defined as the sum of ciliary redness (0-4 scale, from 0=none to 4=extremely severe), conjunctival redness (0-4 scale, from 0=none to 4=extremely severe), and episcleral redness (0-4 scale, from 0=none to 4=extremely severe). Average of total redness score over both eyes was analyzed.
    Time Frame
    7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment
    Title
    Mean Ocular Itching at 24 Hours Duration of Action
    Description
    A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.
    Time Frame
    3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment
    Title
    Mean Conjunctival Redness at 24 Hours Duration of Action
    Description
    A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none to 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
    Time Frame
    7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment

    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. Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of Visit 1. History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1. Positive bilateral CAC response at Visit 1 and Visit 2. 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 requiring frequent use (> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes. Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes. Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of Visit 1. Presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the Investigator is likely to advance/worsen during the time course of the study. Any contraindications or hypersensitivities to the use of the study medication or their components. 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

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    Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model

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