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

NCT04206020 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 19-110-0011
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 4

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.

Conditions

Dry Eye Syndrome

Keywords

Dry Eye; Dry Eye Syndrome; SkQ1; KCS; Keratoconjunctivitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Placebo Comparator: SkQ1 Vehicle

PLACEBO COMPARATOR

Vehicle for SkQ1 Ophthalmic Solution

Drug: SkQ1 Vehicle Solution

SkQ1

ACTIVE COMPARATOR

SkQ1 Ophthalmic Solution

Drug: SkQ1 Ophthalmic Solution

Interventions

SkQ1 Vehicle Solution DRUG

SkQ1 Ophthalmic Solution Vehicle

Also known as: Vehicle for SkQ1

Placebo Comparator: SkQ1 Vehicle

SkQ1 Ophthalmic Solution DRUG

SkQ1 Ophthalmic Solution

Also known as: Visomitin

SkQ1

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: self-representation
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Mitotech, SA: lead
• ORA, Inc.: collaborator

Study Sites (4)

Arizona Eye Institute and Cosmetic Laser

Sun City West, Arizona, 85375, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Eye Clinics of South Texas

San Antonio, Texas, 78209, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis

Interventions

Visomitin

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Results Point of Contact

• Title: Chief Operating Officer
• Organization: Mitotech S.A.

info@mitotechpharma.com

+352621692785

Study Officials

• Lawrence T Friedhoff, MD, PhD

  Mitotech, SA

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: December 20, 2019
• Primary Completion: October 6, 2020
• Study Completion: October 6, 2020
• Last Updated: January 19, 2022
• Results First Posted: January 19, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)