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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