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

Phase 2

Completed

Interventions: Drug: Placebo (Vehicle) opthalmic solution
Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution
Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution

Brief 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.

Detailed Description: Single-center, double-masked, randomized, placebo-controlled study comprising 4 visits over the course of approximately 5 weeks. The study included a 1-week placebo (SkQ1 vehicle) run-in period between Visit 1 and Visit 2, and approximately 28 days of twice daily (BID) dosing (Visit 2 - Visit 4). Qualified subjects were randomized 1:1:1 to receive either 1.55 µg/mL SkQ1 ophthalmic solution, 0.155 µg/mL SkQ1 ophthalmic solution, or placebo (vehicle of SkQ1 ophthalmic solution).

The following primary endpoints were tested:

* Corneal Fluorescein staining in the inferior region Pre-CAE at Visit 4 (Day 29), as measured by the Ora Calibra Scale in the worst eye at baseline;

* Worst dry eye symptom (ocular discomfort, dryness, or grittiness - as determined from subject diary data recorded during the 1-week run-in period between Visit 1 and Visit 2) evaluated over the seven days preceding Visit 4 (not including day of visit) during the treatment period.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Placebo (vehicle)	Placebo (Vehicle) opthalmic solution	Drug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days
Low Dose SkQ1	Low Dose 0.155µg/mL SkQ1 ophthalmic solution	Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days
High Dose SkQ1	High Dose 1.55µg/mL SkQ1 ophthalmic solution	Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days

Primary Outcome Measures

Name	Time	Method
Inferior Corneal Fluorescein Staining	Day 29	The dry eye sign primary efficacy variable of corneal fluorescein staining of the inferior region of the eye measured on a 0-4 point scale where 0 = no staining and 4 = most staining between treatment arms at day 29
Worst Symptom Based on Diary Data	Day 29	Worst dry eye symptom (as determined from subject diary data recorded during the 1-week run-in period) evaluated over the seven days preceding Day 29 during the treatment period. The scale was on a 0-5 range where 0= no symptoms and 5= worst symptoms measured for a number of dry eye symptoms.

Secondary Outcome Measures