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A Multi-Center, Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle

This study has been completed.
Information provided by (Responsible Party):
Aciex Therapeutics, Inc. Identifier:
First received: June 17, 2013
Last updated: April 30, 2015
Last verified: April 2015
The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% 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 0.24%
Drug: AC-170 0%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of AC-170 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Ocular itching at defined time points up to 2 weeks [ Time Frame: Baseline to day 14 ]
  • Ocular redness at defined time points up to 2 weeks [ Time Frame: Baseline to day 14 ]

Enrollment: 101
Study Start Date: June 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AC-170 0.24% Drug: AC-170 0.24%
1 drop in each eye at 2 separate times during a 14 day period
Placebo Comparator: AC-170 0% Drug: AC-170 0%
1 drop in each eye at 2 separate times during a 14 day period


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 trial parameters
  • use of disallowed medication during the period indicated prior to the enrollment or during the study
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Please refer to this study by its identifier: NCT01881113

United States, Ohio
Cincinnati, Ohio, United States
Mason, Ohio, United States
United States, Tennessee
Memphis, Tennessee, United States
Sponsors and Collaborators
Aciex Therapeutics, Inc.
  More Information

Responsible Party: Aciex Therapeutics, Inc. Identifier: NCT01881113     History of Changes
Other Study ID Numbers: 13-100-0002
Study First Received: June 17, 2013
Last Updated: April 30, 2015

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 23, 2017