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:
Information provided by (Responsible Party):
Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01685242
First received: September 12, 2012
Last updated: November 20, 2012
Last verified: November 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Ocular redness at defined time points up to 2 weeks [ Time Frame: Baseline to day 14 ] [ Designated as safety issue: No ]

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

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 trial parameters
  • use of disallowed medication during the period indicated prior to the enrollment or during the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685242

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

No publications provided

Responsible Party: Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01685242     History of Changes
Other Study ID Numbers: 12-100-0006
Study First Received: September 12, 2012
Last Updated: November 20, 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 April 15, 2014