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

Akorn, Inc.90 enrolled

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

AKF-1DRUG

1 drop AKF-1 0.025% in each eye at 2 separate times during a 14 day period

AKF-1DRUG

1 drop AKF-1 0.035% in each eye at 2 separate times during a 14 day period

AKF-1DRUG

1 drop 0% in each eye at 2 separate times during a 14 day period

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

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

Locations (1)

Andover Eye Associates

Andover, Massachusetts, United States

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.