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

Phase 3

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: AKF-1

• Registration Number: NCT01561521
• Lead Sponsor: Akorn, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-05
• Disposition First Submitted: 2013-07-16
• Disposition First Submitted QC: 2013-07-16
• Last Update Submitted: 2013-07-16
• Disposition First Posted: 2013-07-18
• Last Update Posted: 2013-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AKF-1 0.025%	AKF-1	-
AKF-1 0.035%	AKF-1	-
AKF-1 0%	AKF-1	-

Primary Outcome Measures

Name	Time	Method
Ocular Itching at defined time points up to 2 weeks	Baseline to day 14
Ocular Redness at defined time points up to 2 weeks	Baseline to day 14

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States