Study of SkQ1 as Treatment for Dry-eye Syndrome

NCT03764735 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 18-110-0004
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 7

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.

Conditions

Dry Eye Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

SkQ1 Vehicle

PLACEBO COMPARATOR

SkQ1 (Vehicle)

Drug: SkQ1 (Vehicle)

Low Dose - SkQ1

ACTIVE COMPARATOR

Low-dose ophthalmic solution

Drug: Low Dose - SkQ1

High Dose - SkQ1

ACTIVE COMPARATOR

High-dose ophthalmic solution

Drug: High dose - SkQ1

Interventions

Low Dose - SkQ1 DRUG

SkQ1 Low dose ophthalmic solution

Also known as: Visomitin

Low Dose - SkQ1

High dose - SkQ1 DRUG

SkQ1 High Dose ophthalmic solution

Also known as: Visomitin

High Dose - SkQ1

SkQ1 (Vehicle) DRUG

Vehicle for SkQ1 ophthalmic solution

SkQ1 Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• 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 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;

Sponsors & Collaborators

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

Study Sites (7)

Cornea & Cataract Consultants of Arizona

Phoenix, Arizona, 85032, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Eye Care Insititute

Louisville, Kentucky, 40206, United States

Location

Central Maine Eye Care

Lewiston, Maine, 04240, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Vita Eye Clinic

Shelby, North Carolina, 28150, United States

Location

Total Eye Care, PA

Memphis, Tennessee, 38119, 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-group study of two strengths of ophthalmic solution versus placebo solution

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 5, 2018
• Study Start: December 6, 2018
• Primary Completion: February 9, 2019
• Study Completion: February 9, 2019
• 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 (7)