An Evaluation of the Onset and Duration of Action of AKF-1 Ophthalmic Solution in Treating Acute Allergic Conjunctivitis

Overview

The purpose of this study is to evaluate the onset and duration of action of two concentrations of AKF-1 Ophthalmic Solution compared to vehicle in the conjunctival allergen challenge (CAC) model of acute allergic conjunctivitis.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2012

Interventions

  • Drug: AKF-1
    • 1 drop AKF-1 0.025% in each eye at 2 separate times during a 14 day period
  • Drug: AKF-1
    • 1 drop AKF-1 0.035% in each eye at 2 separate times during a 14 day period
  • Drug: AKF-1
    • 1 drop 0% in each eye at 2 separate times during a 14 day period

Arms, Groups and Cohorts

  • Experimental: AKF-1 0.025%
  • Experimental: AKF-1 0.035%
  • Placebo Comparator: AKF-1 0%

Clinical Trial Outcome Measures

Primary Measures

  • Ocular Itching at defined time points up to 2 weeks
    • Time Frame: Baseline to day 14
  • Ocular Redness at defined time points up to 2 weeks
    • Time Frame: Baseline to day 14

Participating in This Clinical Trial

Inclusion Criteria

  • positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria

  • known contraindications or sensitivities to the study medication or its components
  • any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters
  • use of disallowed medication during the period indicated prior to the enrollment or during the study

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Akorn, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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