Text Size

Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01134328
First received: May 28, 2010
Last updated: February 27, 2012
Last verified: February 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-CAC™ Model.


Condition Intervention Phase
Allergic Conjunctivitis
 Drug: AC-150
Drug: AC-150A
Drug: AC-150B
Drug: Vehicle
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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 [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
  • Ocular Redness [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: May 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AC-150 Drug: AC-150
1 drop in each eye for up to 14 days
Active Comparator: AC-150A Drug: AC-150A
1 drop in each eye once per day for up to 14 days
Active Comparator: AC-150B Drug: AC-150B
1 drop in each eye once per day for up to 14 days
Vehicle Drug: Vehicle
1 drop in each eye once per day for up to 14 days

  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 study enrollment or during the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134328

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: NCT01134328     History of Changes
Other Study ID Numbers: 10-100-0005
Study First Received: May 28, 2010
Last Updated: February 27, 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 16, 2013