A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | April 2014 |
A Phase 2, Single-Center, Randomized, Double-Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution in the Environment and During Challenge in the CAE(SM) Model for the Treatment of Dry Eye Syndrome
The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and
effective compared to placebo for the treatment of the signs and symptoms of dry eye
syndrome.
effective compared to placebo for the treatment of the signs and symptoms of dry eye
syndrome.
Inclusion Criteria:
- Be male or female of any race, at least 18 years of age
- Have provided written informed consent
- Have a reported history of dry eye syndrome
- Have a history of use or desire to use eye drops for dry eye
Exclusion Criteria:
- Have any clinically significant eye findings that require therapeutic treatment or may
interfere with study parameters
- Have previously had LASIK surgery within the last 12 months
- Have used Restasis® within 30 days of Visit 1
- Be a woman who is pregnant, nursing or planning a pregnancy
- Be unwilling to submit a urine pregnancy test if of childbearing potential
- Have a known allergy and/or sensitivity to the test article or its components,
including the preservative benzalkonium chloride
- Be currently enrolled in an investigational drug or device study or have used an
investigational drug or device within 30 days of Visit 1
- Have a condition or be in a situation which the investigator feels may put the subject
at significant risk, may confound the study results, or may interfere significantly
with the subject's participation in the study
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