Study of SkQ1 as Treatment for Dry-eye Syndrome

Study Overview
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Brief Summary
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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
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Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. Qualified subjects are randomized 1:1:1 to receive either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo (vehicle of SkQ1 ophthalmic solution). The Primary Endpoints are: Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining; Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom

Official Title
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A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution for the Treatment of Dry Eye Syndrome

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: Low Dose - SkQ1
* Drug: High dose - SkQ1
* Drug: SkQ1 (Vehicle)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age; Provide written informed consent; Have a subject reported history of dry eye; Have a history of use of eye drops for dry eye symptoms ; Ocular Discomfort; Schirmer's Test score; Have corneal fluorescein staining ; Have lissamine green conjunctival Staining ; Have a conjunctival redness; Exclusion Criteria: Have participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study; Have any clinically significant slit lamp findings at Visit 1; Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit 1; Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned over the study period; Have an uncontrolled systemic disease; Be a woman who is pregnant, nursing or planning a pregnancy; Be a woman of childbearing potential who is not using an acceptable means of birth control; Have a known allergy and/or sensitivity to the study drug or its components ; 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; Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel-group study of two strengths of ophthalmic solution versus placebo solution
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: SkQ1 Vehicle<br>SkQ1 (Vehicle) | Drug: SkQ1 (Vehicle)<br>* Vehicle for SkQ1 ophthalmic solution<br>|
| Active Comparator: Low Dose - SkQ1<br>Low-dose ophthalmic solution | Drug: Low Dose - SkQ1<br>* SkQ1 Low dose ophthalmic solution<br>* Other names: Visomitin;|
| Active Comparator: High Dose - SkQ1<br>High-dose ophthalmic solution | Drug: High dose - SkQ1<br>* SkQ1 High Dose ophthalmic solution<br>* Other names: Visomitin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central Corneal Staining Change From Baseline | Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe | From baseline to Day 57 | 
| Grittiness Change From Baseline | Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst | From baseline to Day 57 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, Dry Eye Syndrome, SkQ1, KCS, Keratoconjunctivitis