Clinical trial NCT03764735: Study of SkQ1 as Treatment for Dry-eye Syndrome
Official title: A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution for the Treatment of Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndrome
Keywords: Dry Eye
Dry Eye Syndrome
SkQ1
KCS
Keratoconjunctivitis
Lead sponsor: Mitotech, SA
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2018-12-05
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-group study of two strengths of ophthalmic solution versus placebo solution
Primary purpose: TREATMENT

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

Eligibility criteria: 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;

Primary outcomes:
measure: Central Corneal Staining Change From Baseline
timeFrame: From baseline to Day 57
measure: Grittiness Change From Baseline
timeFrame: From baseline to Day 57
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea & Cataract Consultants of Arizona
state: Arizona
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Louisville
country: United States
facility: Eye Care Insititute
state: Kentucky
city: Lewiston
country: United States
facility: Central Maine Eye Care
state: Maine
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Shelby
country: United States
facility: Vita Eye Clinic
state: North Carolina
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
Study officials:
affiliation: Mitotech, SA
name: Lawrence T Friedhoff, MD, PhD
role: STUDY_CHAIR
References: