A Comparison of the Safety and Comfort of AC-170

Overview

The purpose of this study is to evaluate the safety and comfort of AC-170 compared to a placebo.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 2011

Interventions

  • Drug: AC-170 0.17%
    • 1 drop in one eye at one timepoint
  • Drug: AC-170 0.24% (Formulation 1)
    • 1 drop in one eye at one timepoint
  • Drug: AC-170 0.24% (Formulation 2)
    • 1 drop in one eye at one timepoint
  • Drug: Olopatadine hydrochloride 0.2%/Tears Naturale II
    • 1 drop in one eye at one timepoint

Arms, Groups and Cohorts

  • Experimental: AC-170 0.17%
  • Experimental: AC-170 0.24% (Formulation 1)
  • Experimental: AC-170 0.24% (Formulation 2)
  • Placebo Comparator: Olopatadine hydrochloride 0.2%/Tears Naturale II

Clinical Trial Outcome Measures

Primary Measures

  • Drop Comfort Score
    • Time Frame: during 3 minute period
    • drop comfort on 0-10 scale

Participating in This Clinical Trial

Inclusion Criteria

  • Able and willing to avoid the use of ocular medications or topical ocular preparations within protocol specific time period. 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 the study enrollment or during the study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aciex Therapeutics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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