Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome (VISTA-2)
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ClinicalTrials.gov Identifier: NCT04206020 |
Recruitment Status :
Active, not recruiting
First Posted : December 20, 2019
Last Update Posted : August 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye Syndrome | Drug: SkQ1 Vehicle Solution Drug: SkQ1 Ophthalmic Solution | Phase 3 |
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)
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 610 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Parallel Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | December 3, 2019 |
Estimated Primary Completion Date : | October 2020 |
Estimated Study Completion Date : | October 2020 |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo Comparator: SkQ1 Vehicle
Vehicle for SkQ1 Ophthalmic Solution
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Drug: SkQ1 Vehicle Solution
SkQ1 Ophthalmic Solution Vehicle
Other Name: Vehicle for SkQ1 |
Active Comparator: SkQ1
SkQ1 Ophthalmic Solution
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Drug: SkQ1 Ophthalmic Solution
SkQ1 Ophthalmic Solution |
- Ocular Discomfort Scale [ Time Frame: From baseline to Day 57 ]Change of Ocular Discomfort Scale
- Conjunctival Fluorescein Staining [ Time Frame: From baseline to Day 57 ]Change of Conjunctival Fluroscein Staining (sum of temporal and nasal regions)
- Ocular Discomfort Scale [ Time Frame: From Baseline to Day 29 ]Change from Baseline of Ocular Discomfort on Day 29
- Conjunctival Fluorescein Staining [ Time Frame: From Baseline to Day 43 ]Change from baseline of conjunctival fluorescein staining (sum of temporal and nasal regions) to Day 43
- Tear Film Breakup Time During Controlled Adverse Environment (CAE®) [ Time Frame: Day 57 ]Tear film break-up time pre- to post-CAE®
- Corneal Fluorescein Staining [ Time Frame: Baseline to Day 29 ]Change from baseline of corneal fluorescein staining in central region on Day 29

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | self-representation |
Accepts Healthy Volunteers: | No |
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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04206020
United States, Arizona | |
Arizona Eye Institute and Cosmetic Laser | |
Sun City West, Arizona, United States, 85375 | |
United States, Massachusetts | |
Andover Eye Associates | |
Andover, Massachusetts, United States, 01810 | |
United States, Texas | |
Eye Clinics of South Texas | |
San Antonio, Texas, United States, 78209 | |
United States, Virginia | |
Piedmont Eye Center | |
Lynchburg, Virginia, United States, 24502 |
Study Chair: | Lawrence T Friedhoff, MD, PhD | Mitotech, SA |
Responsible Party: | Mitotech, SA |
ClinicalTrials.gov Identifier: | NCT04206020 |
Other Study ID Numbers: |
19-110-0011 |
First Posted: | December 20, 2019 Key Record Dates |
Last Update Posted: | August 18, 2020 |
Last Verified: | December 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Dry Eye Dry Eye Syndrome SkQ1 KCS Keratoconjunctivitis |
Keratoconjunctivitis Sicca Dry Eye Syndromes Syndrome Disease Pathologic Processes Keratoconjunctivitis Conjunctivitis |
Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Pharmaceutical Solutions Ophthalmic Solutions |