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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01332188
First received: April 7, 2011
Last updated: July 10, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Allergic Conjunctivitis
Drug: AC-170 0.05%
Drug: AC-170 0.1%
Drug: AC-170 0.24%
Drug: AC-170 0%
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Aciex Therapeutics, Inc.:

Primary Outcome Measures:
  • Ocular Itching at defined timepoints up to 3 weeks [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]
  • Ocular Redness at defined timepoints up to 3 weeks [ Time Frame: Baseline to Day 21 ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: April 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AC-170 0.05% Drug: AC-170 0.05%
1 drop in each eye at 3 separate times during a 21 day period
Experimental: AC-170 0.1% Drug: AC-170 0.1%
1 drop in each eye at 3 separate times during a 21 day period
Experimental: AC-170 0.24% Drug: AC-170 0.24%
1 drop in each eye at 3 separate times during a 21 day period
Placebo Comparator: AC-170 0% Drug: AC-170 0%
1 drop in each eye at 3 separate times during a 21 day period

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332188

Locations
United States, Massachusetts
Ora, Inc.
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Aciex Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01332188     History of Changes
Other Study ID Numbers: 11-100-0004
Study First Received: April 7, 2011
Last Updated: July 10, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on October 23, 2014