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

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.

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AKF-1

Drug

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

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

Sponsors and collaborators

Lead sponsor

Akorn, Inc.

Industry

Registry information

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Mar 23, 2012
Registry last updated: Jul 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed