Study of SkQ1 as Treatment for Dry-eye Syndrome (VISTA-1)

Mitotech

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndrome

Treatments: Drug: Low Dose - SkQ1; Drug: SkQ1 (Vehicle); Drug: High dose - SkQ1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03764735

18-110-0004

Details and patient eligibility

About

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.

Full description

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

Enrollment: 452 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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452 participants in 3 patient groups, including a placebo group

SkQ1 Vehicle

Placebo Comparator group

Description:

SkQ1 (Vehicle)

Treatment:

Drug: SkQ1 (Vehicle)

Low Dose - SkQ1

Active Comparator group

Description:

Low-dose ophthalmic solution

Treatment:

Drug: Low Dose - SkQ1

High Dose - SkQ1

Active Comparator group

Description:

High-dose ophthalmic solution

Treatment:

Drug: High dose - SkQ1