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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: SkQ1 Vehicle Solution; Drug: SkQ1 Ophthalmic Solution

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
• Enrollment (Actual): 610
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Sun City West, Arizona, United States, 85375
      • Arizona Eye Institute and Cosmetic Laser
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
  • Texas
    • San Antonio, Texas, United States, 78209
      • Eye Clinics of South Texas
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • Piedmont Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator: SkQ1 Vehicle; Vehicle for SkQ1 Ophthalmic Solution	Drug: SkQ1 Vehicle Solution; SkQ1 Ophthalmic Solution Vehicle; Other Names: Vehicle for SkQ1
Active Comparator: SkQ1; SkQ1 Ophthalmic Solution	Drug: SkQ1 Ophthalmic Solution; SkQ1 Ophthalmic Solution; Other Names: Visomitin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular Discomfort Scale	Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.	From baseline to Day 57
Conjunctival Fluorescein Staining	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	From baseline to Day 57

Collaborators and Investigators

• Sponsor: Mitotech, SA
• Collaborators: ORA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Actual): October 6, 2020
• Study Completion (Actual): October 6, 2020

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Dry Eye; Dry Eye Syndrome; Keratoconjunctivitis; SkQ1; KCS
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: 19-110-0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No