Vehicle-Controlled 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 Solution is safe and effective compared to Vehicle 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 to receive either SkQ1 Ophthalmic Solution, or Placebo (vehicle of SkQ1 Ophthalmic Solution). The Primary Endpoints are: Change from Baseline (Visit 2) to Visit 5 of Ocular Discomfort; Change from Baseline (Visit 2) to Visit 5 of conjunctival fluorescein staining (sum of temporal and nasal regions)

Official Title
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A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study of Safety and Efficacy of SkQ1 Ophthalmic Solution in the Environment and the Controlled Adverse Environmental (CAE®) Model for the Treatment of Dry Eye Syndrome

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: SkQ1 Vehicle Solution
* Drug: SkQ1 Ophthalmic Solution


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 been previously exposed to previous SkQ1 Ophthalmic Solution treatment; 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 Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Comparator: SkQ1 Vehicle<br>Vehicle for SkQ1 Ophthalmic Solution | Drug: SkQ1 Vehicle Solution<br>* SkQ1 Ophthalmic Solution Vehicle<br>* Other names: Vehicle for SkQ1;|
| Active Comparator: SkQ1<br>SkQ1 Ophthalmic Solution | Drug: SkQ1 Ophthalmic Solution<br>* SkQ1 Ophthalmic Solution<br>* Other names: Visomitin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Discomfort Scale | Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort. | From baseline to Day 57 | 
| Conjunctival Fluorescein Staining | Change of Conjunctival Fluorescein Staining (sum of temporal and nasal regions), scale in each region ranged from 0 to 4 with 0 = No Staining and 4 = Confluent Staining | 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