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Study of SkQ1 as Treatment for Dry-eye Syndrome (VISTA-1)

Primary Purpose

Dry Eye Syndrome

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Low Dose - SkQ1

High dose - SkQ1

SkQ1 (Vehicle)

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye, Dry Eye Syndrome, SkQ1, KCS, Keratoconjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

Cornea & Cataract Consultants of Arizona
Eye Research Foundation
Eye Care Insititute
Central Maine Eye Care
Andover Eye Associates
Vita Eye Clinic
Total Eye Care, PA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

SkQ1 Vehicle

Low Dose - SkQ1

High Dose - SkQ1

Arm Description

SkQ1 (Vehicle)

Low-dose ophthalmic solution

High-dose ophthalmic solution

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03764735

First Posted

November 30, 2018

Last Updated

December 20, 2021

Sponsor

Mitotech, SA

Collaborators

ORA, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03764735

Brief Title

Study of SkQ1 as Treatment for Dry-eye Syndrome

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

December 6, 2018 (Actual)

Primary Completion Date

February 9, 2019 (Actual)

Study Completion Date

February 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitotech, SA

Collaborators

ORA, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndrome

Keywords

Dry Eye, Dry Eye Syndrome, SkQ1, KCS, Keratoconjunctivitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Parallel-group study of two strengths of ophthalmic solution versus placebo solution

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

452 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SkQ1 Vehicle

Arm Type

Placebo Comparator

Arm Description

SkQ1 (Vehicle)

Arm Title

Low Dose - SkQ1

Arm Type

Active Comparator

Arm Description

Low-dose ophthalmic solution

Arm Title

High Dose - SkQ1

Arm Type

Active Comparator

Arm Description

High-dose ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

Low Dose - SkQ1

Other Intervention Name(s)

Visomitin

Intervention Description

SkQ1 Low dose ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

High dose - SkQ1

Other Intervention Name(s)

Visomitin

Intervention Description

SkQ1 High Dose ophthalmic solution

Intervention Type

Drug

Intervention Name(s)

SkQ1 (Vehicle)

Intervention Description

Vehicle for SkQ1 ophthalmic solution

Primary Outcome Measure Information:

Title

Central Corneal Staining Change From Baseline

Description

Change of Corneal Fluorescein Staining from baseline to Day 57, scale ranges from 0 to 4, where grade 0 = None, 4 = Severe

Time Frame

From baseline to Day 57

Title

Grittiness Change From Baseline

Description

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

Time Frame

From baseline to Day 57

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lawrence T Friedhoff, MD, PhD

Organizational Affiliation

Mitotech, SA

Official's Role

Study Chair

Facility Information:

Facility Name

Cornea & Cataract Consultants of Arizona

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

Eye Research Foundation

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Eye Care Insititute

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40206

Country

United States

Facility Name

Central Maine Eye Care

City

Lewiston

State/Province

Maine

ZIP/Postal Code

04240

Country

United States

Facility Name

Andover Eye Associates

City

Andover

State/Province

Massachusetts

ZIP/Postal Code

01810

Country

United States

Facility Name

Vita Eye Clinic

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28150

Country

United States

Facility Name

Total Eye Care, PA

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of SkQ1 as Treatment for Dry-eye Syndrome

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