A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome
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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
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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