Study of SkQ1 as Treatment for Dry-eye Syndrome

Phase 3

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: SkQ1 (Vehicle); Drug: Low Dose - SkQ1; Drug: High dose - SkQ1

• Registration Number: NCT03764735
• Lead Sponsor: Mitotech, SA

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 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 Timeline

• Study First Submitted: 2018-11-30
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-05
• Study Start: 2018-12-06
• Primary Completion: 2019-02-09
• Study Completion: 2019-02-09
• Status Verified: 2021-12
• Results First Submitted: 2021-12-20
• Results First Submitted QC: 2021-12-20
• Last Update Submitted: 2021-12-20
• Results First Posted: 2022-01-19
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SkQ1 Vehicle	SkQ1 (Vehicle)	SkQ1 (Vehicle)
Low Dose - SkQ1	Low Dose - SkQ1	Low-dose ophthalmic solution
High Dose - SkQ1	High dose - SkQ1	High-dose ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Central Corneal Staining Change From Baseline	From baseline to Day 57	Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe
Grittiness Change From Baseline	From baseline to Day 57	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

Trial Locations

Locations (7)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States

Cornea & Cataract Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Vita Eye Clinic; 🇺🇸 Shelby, North Carolina, United States

Eye Care Insititute; 🇺🇸 Louisville, Kentucky, United States

Central Maine Eye Care; 🇺🇸 Lewiston, Maine, United States

Total Eye Care, PA; 🇺🇸 Memphis, Tennessee, United States