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

This study has been completed.
Information provided by (Responsible Party):
Aciex Therapeutics, Inc. Identifier:
First received: May 28, 2010
Last updated: February 27, 2012
Last verified: February 2012
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 (Participant, 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 ]
  • Ocular Redness [ Time Frame: Baseline to Day 14 ]

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


Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01134328

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

Responsible Party: Aciex Therapeutics, Inc. Identifier: NCT01134328     History of Changes
Other Study ID Numbers: 10-100-0005
Study First Received: May 28, 2010
Last Updated: February 27, 2012

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases processed this record on July 25, 2017