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Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome (VISTA-2)

Primary Purpose

Dry Eye Syndrome

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

SkQ1 Vehicle Solution

SkQ1 Ophthalmic Solution

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 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;

Sites / Locations

Arizona Eye Institute and Cosmetic Laser
Andover Eye Associates
Eye Clinics of South Texas
Piedmont Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Comparator: SkQ1 Vehicle

SkQ1

Arm Description

Vehicle for SkQ1 Ophthalmic Solution

SkQ1 Ophthalmic Solution

Outcomes

Primary Outcome Measures

Ocular Discomfort Scale

Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04206020

First Posted

December 18, 2019

Last Updated

December 20, 2021

Sponsor

Mitotech, SA

Collaborators

ORA, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04206020

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

December 20, 2019 (Actual)

Primary Completion Date

October 6, 2020 (Actual)

Study Completion Date

October 6, 2020 (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 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)

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 Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

610 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Comparator: SkQ1 Vehicle

Arm Type

Placebo Comparator

Arm Description

Vehicle for SkQ1 Ophthalmic Solution

Arm Title

SkQ1

Arm Type

Active Comparator

Arm Description

SkQ1 Ophthalmic Solution

Intervention Type

Drug

Intervention Name(s)

SkQ1 Vehicle Solution

Other Intervention Name(s)

Vehicle for SkQ1

Intervention Description

SkQ1 Ophthalmic Solution Vehicle

Intervention Type

Drug

Intervention Name(s)

SkQ1 Ophthalmic Solution

Other Intervention Name(s)

Visomitin

Intervention Description

SkQ1 Ophthalmic Solution

Primary Outcome Measure Information:

Title

Ocular Discomfort Scale

Description

Change of Ocular Discomfort Scale, scale ranged from 0 to 4 with 0 = No Discomfort and 4 = Constant Discomfort.

Time Frame

From baseline to Day 57

Title

Conjunctival Fluorescein Staining

Description

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

Time Frame

From baseline to Day 57

10. Eligibility

Sex

All

Gender Based

Yes

Gender Eligibility Description

self-representation

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 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;

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

Arizona Eye Institute and Cosmetic Laser

City

Sun City West

State/Province

Arizona

ZIP/Postal Code

85375

Country

United States

Facility Name

Andover Eye Associates

City

Andover

State/Province

Massachusetts

ZIP/Postal Code

01810

Country

United States

Facility Name

Eye Clinics of South Texas

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

Facility Name

Piedmont Eye Center

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24502

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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