Phase 2, Single-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophth Sol'n in the Environment and During Challenge in the Controlled Adverse Environment (CAE) Model for the Treatment of DES
Overview
- Phase
- Phase 2
- Intervention
- Low Dose 0.155µg/mL SkQ1 ophthalmic solution
- Conditions
- Keratoconjunctivitis Sicca
- Sponsor
- Mitotech, SA
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- Inferior Corneal Fluorescein Staining
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Low Dose SkQ1
Drug: Low Dose 0.155µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days
Intervention: Low Dose 0.155µg/mL SkQ1 ophthalmic solution
High Dose SkQ1
Drug: High Dose 1.55µg/mL SkQ1 ophthalmic solution administered twice daily for 28 days
Intervention: High Dose 1.55µg/mL SkQ1 ophthalmic solution
Placebo (vehicle)
Drug: Placebo (vehicle) ophthalmic solution administered twice daily for 28 days
Intervention: Placebo (Vehicle) opthalmic solution
Outcomes
Primary Outcomes
Inferior Corneal Fluorescein Staining
Time Frame: 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
Time Frame: 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.