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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
History of Changes
  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:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

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
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, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013