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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

  • Mean Ocular Itching at Onset of Action [ Time Frame: 3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment ]
    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 [ Time Frame: 3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment ]
    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.


    • Original Primary Outcome: Ocular Itching [ Time Frame: 3 minutes and 24 hours ]

    Ocular Itching Assessment at Onset and at Duration of Action timepoints


    Current Secondary Outcome:

    • Mean Conjunctival Redness at Onset of Action [ Time Frame: 7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment ]
      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 [ Time Frame: 7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment ]
      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 [ Time Frame: 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment ]
      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 [ Time Frame: 3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment ]
      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 [ Time Frame: 7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment ]
      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.


    Original Secondary Outcome:

    • Conjunctival redness [ Time Frame: 3 minutes and 24 hours ]
    • Total redness [ Time Frame: 24 hours ]
      sum of conjunctival, episcleral and ciliary redness


    Information By: Alcon Research

    Dates:
    Date Received: November 22, 2011
    Date Started: January 2012
    Date Completion:
    Last Updated: May 28, 2013
    Last Verified: May 2013