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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01685242
First Posted: September 14, 2012
Last Update Posted: May 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aciex Therapeutics, Inc.
  Purpose
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 (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Double-Masked, Randomization, 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: 100
Study Start Date: September 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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 trial parameters
  • use of disallowed medication during the period indicated prior to the enrollment or during the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685242


Locations
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Aciex Therapeutics, Inc.
  More Information

Responsible Party: Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01685242     History of Changes
Other Study ID Numbers: 12-100-0006
First Submitted: September 12, 2012
First Posted: September 14, 2012
Last Update Posted: May 19, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
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


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