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

Phase 3

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: SkQ1 Vehicle Solution; Drug: SkQ1 Ophthalmic Solution

• Registration Number: NCT04206020
• Lead Sponsor: Mitotech, SA

Brief 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.

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 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)

Study Timeline

• Study First Submitted: 2019-12-18
• Study First Submitted QC: 2019-12-18
• Study Start: 2019-12-20
• Study First Posted: 2019-12-20
• Primary Completion: 2020-10-06
• Study Completion: 2020-10-06
• 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: 610

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 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 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
Placebo Comparator: SkQ1 Vehicle	SkQ1 Vehicle Solution	Vehicle for SkQ1 Ophthalmic Solution
SkQ1	SkQ1 Ophthalmic Solution	SkQ1 Ophthalmic Solution

Primary Outcome Measures

Name	Time	Method
Ocular Discomfort Scale	From baseline to Day 57	Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.
Conjunctival Fluorescein Staining	From baseline to Day 57	Change of Conjunctival Fluorescein Staining (sum of temporal and nasal regions), scale in each region ranged from 0 to 4 with 0 = No Staining and 4 = Confluent Staining

Trial Locations

Locations (4)

Arizona Eye Institute and Cosmetic Laser; 🇺🇸 Sun City West, Arizona, United States

Eye Clinics of South Texas; 🇺🇸 San Antonio, Texas, United States

Piedmont Eye Center; 🇺🇸 Lynchburg, Virginia, United States

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