A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitotech, SA
• Collaborator: ORA, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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