Study of SkQ1 as Treatment for Dry-eye Syndrome

Last updated: December 20, 2021
Sponsor: Mitotech, SA
Overall Status: Completed

Phase

3

Condition

Dry Eye Disease

Dry Eyes

Sjogren's Syndrome

Treatment

N/A

Clinical Study ID

NCT03764735
18-110-0004
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 plannedover 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 birthcontrol;
  • 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 subjectat significant risk, may confound the study results, or may interfere significantlywith the subject's participation in the study;
  • Be currently enrolled in an investigational drug or device study or have used aninvestigational drug or device within 30 days of Visit 1;

Study Design

Total Participants: 452
Study Start date:
December 06, 2018
Estimated Completion Date:
February 09, 2019

Study 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

Connect with a study center

  • Cornea & Cataract Consultants of Arizona

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Site Not Available

  • Midwest Cornea Associates

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Eye Care Insititute

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • Central Maine Eye Care

    Lewiston, Maine 04240
    United States

    Site Not Available

  • Andover Eye Associates

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • Vita Eye Clinic

    Shelby, North Carolina 28150
    United States

    Site Not Available

  • Total Eye Care, PA

    Memphis, Tennessee 38119
    United States

    Site Not Available

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