Efficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (CAC) Model

Allergic Conjunctivitis Clinical Trial

— AC-170  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332188
• Other study ID #: 11-100-0004
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 7, 2011
• Last updated: July 10, 2012
• Start date: April 2011

Study information

• Verified date: July 2012
• Source: Aciex Therapeutics, 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 efficacy of different concentrations of AC-170 compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) Model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: June 2011
• 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 medications during the period indicated prior to the study 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:
• AC-170 0.05%
1 drop in each eye at 3 separate times during a 21 day period
• AC-170 0.1%
1 drop in each eye at 3 separate times during a 21 day period
• AC-170 0.24%
1 drop in each eye at 3 separate times during a 21 day period
• AC-170 0%
1 drop in each eye at 3 separate times during a 21 day period

Locations

Country	Name	City	State
United States	Ora, Inc.	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Aciex Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Itching at defined timepoints up to 3 weeks		Baseline to Day 21	No
Primary	Ocular Redness at defined timepoints up to 3 weeks		Baseline to Day 21	No