Study of SkQ1 as Treatment for Dry-eye Syndrome (VISTA-1)

A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution for the Treatment of Dry Eye Syndrome

The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo 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); Drug: Low Dose - SkQ1; Drug: High dose - SkQ1

Detailed Description

Multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. Qualified subjects are randomized 1:1:1 to receive either High Dose SkQ1 ophthalmic solution, Low Dose SkQ1 ophthalmic solution, or Placebo (vehicle of SkQ1 ophthalmic solution).

The Primary Endpoints are:

Change from Baseline (Visit 2) to Visit 5 in Corneal Fluorescein Staining;

Change from Baseline (Visit 2) to Visit 5 in Grittiness Symptom

• Study Type: Interventional
• Enrollment (Actual): 452
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Cornea & Cataract Consultants of Arizona
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Eye Care Insititute
  • Maine
    • Lewiston, Maine, United States, 04240
      • Central Maine Eye Care
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
  • North Carolina
    • Shelby, North Carolina, United States, 28150
      • Vita Eye Clinic
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA

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 participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;
• 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
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: SkQ1 Vehicle; SkQ1 (Vehicle)	Drug: SkQ1 (Vehicle); Vehicle for SkQ1 ophthalmic solution
ACTIVE_COMPARATOR: Low Dose - SkQ1; Low-dose ophthalmic solution	Drug: Low Dose - SkQ1; SkQ1 Low dose ophthalmic solution; Other Names: Visomitin
ACTIVE_COMPARATOR: High Dose - SkQ1; High-dose ophthalmic solution	Drug: High dose - SkQ1; SkQ1 High Dose ophthalmic solution; Other Names: Visomitin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Corneal Staining Change From Baseline	Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe	From baseline to Day 57
Grittiness Change From Baseline	Change of patient-reported grittiness from baseline to Day 57, scale ranges from 0 to 5 for each symptom, where 0 = None and 5 = Worst	From baseline to Day 57

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2018
• Primary Completion (ACTUAL): February 9, 2019
• Study Completion (ACTUAL): February 9, 2019

Study Registration Dates

• First Submitted: November 30, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (ACTUAL): December 5, 2018

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; Anti-Infective Agents, Local; Anti-Infective Agents; Benzalkonium Compounds
• Other Study ID Numbers: 18-110-0004

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