NCT01561521CompletedPhase 3
An Evaluation of the Onset and Duration of Action of AKF-1 Ophthalmic Solution in Treating Acute Allergic Conjunctivitis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Akorn, Inc.
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Ocular Itching at defined time points up to 2 weeks
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 10 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AKF-1 0.025%
Experimental
Intervention: AKF-1 (Drug)
AKF-1 0.035%
Experimental
Intervention: AKF-1 (Drug)
AKF-1 0%
Placebo Comparator
Intervention: AKF-1 (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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