Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome

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

Phase

3

Condition

Sjogren's Syndrome

Eye Disease

Dry Eye Disease

Treatment

N/A

Clinical Study ID

NCT04206020
19-110-0011
  • Ages > 18
  • All Genders

Study 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.

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 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 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: 610
Study Start date:
December 20, 2019
Estimated Completion Date:
October 06, 2020

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 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)

Connect with a study center

  • Arizona Eye Institute and Cosmetic Laser

    Sun City West, Arizona 85375
    United States

    Site Not Available

  • Andover Eye Associates

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • Eye Clinics of South Texas

    San Antonio, Texas 78209
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Site Not Available

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