Study of SkQ1 as Treatment for Dry-eye Syndrome

Dry Eye Syndrome Clinical Trial

— VISTA-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764735
• Other study ID #: 18-110-0004
• Status: Completed
• Phase: Phase 3
• Start date: December 6, 2018
• Est. completion date: February 9, 2019

Study information

• Verified date: December 2021
• Source: Mitotech, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: February 9, 2019
• Est. primary completion date: February 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• Low Dose - SkQ1
SkQ1 Low dose ophthalmic solution
• High dose - SkQ1
SkQ1 High Dose ophthalmic solution
• SkQ1 (Vehicle)
Vehicle for SkQ1 ophthalmic solution

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Central Maine Eye Care	Lewiston	Maine
United States	Eye Care Insititute	Louisville	Kentucky
United States	Total Eye Care, PA	Memphis	Tennessee
United States	Eye Research Foundation	Newport Beach	California
United States	Cornea & Cataract Consultants of Arizona	Phoenix	Arizona
United States	Vita Eye Clinic	Shelby	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Mitotech, SA	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Corneal Staining Change From Baseline	Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe	From baseline to Day 57
Primary	Grittiness Change From Baseline	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	From baseline to Day 57