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

Dry Eye Syndrome Clinical Trial

— VISTA-2  

Official title:

A Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study of Safety and Efficacy of SkQ1 Ophthalmic Solution in the Environment and the Controlled Adverse Environmental (CAE®) Model for the Treatment of Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206020
• Other study ID #: 19-110-0011
• Status: Completed
• Phase: Phase 3
• Start date: December 20, 2019
• Est. completion date: October 6, 2020

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 Solution is safe and effective compared to Vehicle 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 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 610
• Est. completion date: October 6, 2020
• Est. primary completion date: October 6, 2020
• 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 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;

Related Conditions & MeSH terms

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

Intervention

Drug:
• SkQ1 Vehicle Solution
SkQ1 Ophthalmic Solution Vehicle
• SkQ1 Ophthalmic Solution
SkQ1 Ophthalmic Solution

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Eye Clinics of South Texas	San Antonio	Texas
United States	Arizona Eye Institute and Cosmetic Laser	Sun City West	Arizona

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	Ocular Discomfort Scale	Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.	From baseline to Day 57
Primary	Conjunctival Fluorescein Staining	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	From baseline to Day 57