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

• ClinicalTrials.gov Identifier: NCT04206020
• Recruitment Status: Active, not recruiting
• First Posted: December 20, 2019
• Last Update Posted: August 18, 2020
• Sponsor: Mitotech, SA
• Collaborator: ORA, Inc.
• Information provided by (Responsible Party): Mitotech, SA

Study Description

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)

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Ocular Discomfort Scale [ Time Frame: From baseline to Day 57 ]
   Change of Ocular Discomfort Scale
2. Conjunctival Fluorescein Staining [ Time Frame: From baseline to Day 57 ]
   Change of Conjunctival Fluroscein Staining (sum of temporal and nasal regions)

Secondary Outcome Measures :

1. Ocular Discomfort Scale [ Time Frame: From Baseline to Day 29 ]
   Change from Baseline of Ocular Discomfort on Day 29
2. 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
3. Tear Film Breakup Time During Controlled Adverse Environment (CAE®) [ Time Frame: Day 57 ]
   Tear film break-up time pre- to post-CAE®
4. Corneal Fluorescein Staining [ Time Frame: Baseline to Day 29 ]
   Change from baseline of corneal fluorescein staining in central region on Day 29

Eligibility Criteria

• 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

Criteria

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;

Contacts and Locations

Locations

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.

Investigators

• Study Chair: Lawrence T Friedhoff, MD, PhD; Mitotech, SA

More Information

• Responsible Party: Mitotech, SA
• ClinicalTrials.gov Identifier: NCT04206020
• Other Study ID Numbers: 19-110-0011
• First Posted: December 20, 2019
• 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

Keywords provided by Mitotech, SA:

Dry Eye; Dry Eye Syndrome; SkQ1; KCS; Keratoconjunctivitis

Additional relevant MeSH terms:

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