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Status:

COMPLETED

Study of SkQ1 as Treatment for Dry-eye Syndrome

Lead Sponsor:

Mitotech, SA

Collaborating Sponsors:

ORA, Inc.

Conditions:

Dry Eye Syndrome

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief 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.

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...

Eligibility Criteria

Inclusion

  • 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

  • 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;

Key Trial Info

Start Date :

December 6 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 9 2019

Estimated Enrollment :

452 Patients enrolled

Trial Details

Trial ID

NCT03764735

Start Date

December 6 2018

End Date

February 9 2019

Last Update

January 19 2022

Active Locations (7)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (7 locations)

1

Cornea & Cataract Consultants of Arizona

Phoenix, Arizona, United States, 85032

2

Eye Research Foundation

Newport Beach, California, United States, 92663

3

Eye Care Insititute

Louisville, Kentucky, United States, 40206

4

Central Maine Eye Care

Lewiston, Maine, United States, 04240