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A Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01551056
First received: March 8, 2012
Last updated: July 10, 2012
Last verified: July 2012

March 8, 2012
July 10, 2012
March 2012
June 2012   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01551056 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Allergic Conjunctivitis
  • Drug: AC-170 0.24%
    1 drop in each eye at 2 separate times during a 14 day period
  • Drug: AC-170 0%
    1 drop in each eye at 2 separate times during a 14 day period
  • Experimental: AC-170 0.24%
    Intervention: Drug: AC-170 0.24%
  • Placebo Comparator: AC-170 0%
    Intervention: Drug: AC-170 0%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
June 2012
June 2012   (final data collection date for primary outcome measure)

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 medication during the period indicated prior to the enrollment or during the study
Both
10 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01551056
11-100-0012
No
Aciex Therapeutics, Inc.
Aciex Therapeutics, Inc.
Not Provided
Not Provided
Aciex Therapeutics, Inc.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP