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

• ClinicalTrials.gov Identifier: NCT04206020
• Recruitment Status: Completed
• First Posted: December 20, 2019
• Results First Posted: January 19, 2022
• Last Update Posted: January 19, 2022
• Sponsor: Mitotech, SA
• Collaborator: ORA, Inc.
• Information provided by (Responsible Party): Mitotech, SA

Tracking Information

• First Submitted Date: December 18, 2019
• First Posted Date: December 20, 2019
• Results First Submitted Date: December 20, 2021
• Results First Posted Date: January 19, 2022
• Last Update Posted Date: January 19, 2022
• Actual Study Start Date: December 20, 2019
• Actual Primary Completion Date: October 6, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 20, 2021)

• 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.
• 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

Original Primary Outcome Measures (submitted: December 18, 2019)

• 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)

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: December 18, 2019)

• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome
• 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
• 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.

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 Type: Interventional
• Study Phase: Phase 3

Study Design

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

• Condition: Dry Eye Syndrome

Intervention

• Drug: SkQ1 Vehicle Solution
  SkQ1 Ophthalmic Solution Vehicle
  Other Name: Vehicle for SkQ1
• Drug: SkQ1 Ophthalmic Solution
  SkQ1 Ophthalmic Solution
  Other Name: Visomitin

Study Arms

• Placebo Comparator: Placebo Comparator: SkQ1 Vehicle
  Vehicle for SkQ1 Ophthalmic Solution
  Intervention: Drug: SkQ1 Vehicle Solution
• Active Comparator: SkQ1
  SkQ1 Ophthalmic Solution
  Intervention: Drug: SkQ1 Ophthalmic Solution

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 16, 2020): 610
• Original Estimated Enrollment (submitted: December 18, 2019): 600
• Actual Study Completion Date: October 6, 2020
• Actual Primary Completion Date: October 6, 2020 (Final data collection date for primary outcome measure)

Eligibility 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;

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: self-representation

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04206020
• Other Study ID Numbers: 19-110-0011
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Mitotech, SA
• Original Responsible Party: Same as current
• Current Study Sponsor: Mitotech, SA
• Original Study Sponsor: Same as current
• Collaborators: ORA, Inc.

Investigators

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

• PRS Account: Mitotech, SA
• Verification Date: December 2021