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

Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01561521
• Other study ID #: 11-100-0008
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2012
• Last updated: July 16, 2013
• Start date: March 2012
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: Akorn, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

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

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Akorn, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Itching at defined time points up to 2 weeks		Baseline to day 14	No
Primary	Ocular Redness at defined time points up to 2 weeks		Baseline to day 14	No