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

Completed · Phase 2 · Has a placebo group

Conditions studied: Keratoconjunctivitis Sicca

In brief

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.

Key facts

Study ID: NCT02121301
Run by: Mitotech, SA
People needed: 91
Starts: 2014-04-01
Expected to finish: 2014-06-01
Last updated by the study team: 2020-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Lawrence General Hospital — Andover, Massachusetts, United States

Full record on ClinicalTrials.gov

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