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Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome (VISTA-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04206020
Recruitment Status : Completed
First Posted : December 20, 2019
Results First Posted : January 19, 2022
Last Update Posted : January 19, 2022
ORA, Inc.
Information provided by (Responsible Party):
Mitotech, SA

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Drug: SkQ1 Vehicle Solution Drug: SkQ1 Ophthalmic Solution Phase 3

Detailed 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 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)

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Study Type : Interventional  (Clinical Trial)
Actual 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 20, 2019
Actual Primary Completion Date : October 6, 2020
Actual Study Completion Date : October 6, 2020

Arm Intervention/treatment
Placebo Comparator: Placebo Comparator: SkQ1 Vehicle
Vehicle for SkQ1 Ophthalmic Solution
Drug: SkQ1 Vehicle Solution
SkQ1 Ophthalmic Solution Vehicle
Other Name: Vehicle for SkQ1

Active Comparator: SkQ1
SkQ1 Ophthalmic Solution
Drug: SkQ1 Ophthalmic Solution
SkQ1 Ophthalmic Solution
Other Name: Visomitin

Primary Outcome Measures :
  1. Ocular Discomfort Scale [ Time Frame: From baseline to Day 57 ]
    Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.

  2. Conjunctival Fluorescein Staining [ Time Frame: From baseline to Day 57 ]
    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

Information from the National Library of Medicine

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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;

Information from the National Library of Medicine

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

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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
Sponsors and Collaborators
Mitotech, SA
ORA, Inc.
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Study Chair: Lawrence T Friedhoff, MD, PhD Mitotech, SA
  Study Documents (Full-Text)

Documents provided by Mitotech, SA:
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Responsible Party: Mitotech, SA
ClinicalTrials.gov Identifier: NCT04206020    
Other Study ID Numbers: 19-110-0011
First Posted: December 20, 2019    Key Record Dates
Results First Posted: January 19, 2022
Last Update Posted: January 19, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mitotech, SA:
Dry Eye
Dry Eye Syndrome
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Pathologic Processes
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Pharmaceutical Solutions
Ophthalmic Solutions