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
  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:


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
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: 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 July 23, 2014