Study of SkQ1 as Treatment for Dry-eye Syndrome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

452 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-06

Study Completion Date

2019-02-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT04206020

Dry Eye Syndrome

COMPLETED PHASE3

A Clinical Study to Assess the Safety and Efficacy of an Ophthalmic Solution (SkQ1) in the Treatment of Dry Eye Syndrome (DES)

NCT02121301

Keratoconjunctivitis Sicca

COMPLETED PHASE2

The TRANQUILITY Trial: Clinical Trial to Assess the Efficacy and Safety in Subjects With Dry Eye Disease

NCT04674358

Dry Eye Dry Eye Syndromes

COMPLETED PHASE2/PHASE3

Study of INS365 Ophthalmic Solution in Subjects With Dry Eye Disease

NCT00403715

Dry Eye Disease

COMPLETED PHASE3

Effect of Cequa™ in Subjects With Dry Eye Disease

NCT04357795

Dry Eye Disease

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SkQ1 Vehicle

SkQ1 (Vehicle)

Group Type PLACEBO_COMPARATOR

SkQ1 (Vehicle)

Intervention Type DRUG

Vehicle for SkQ1 ophthalmic solution

Low Dose - SkQ1

Low-dose ophthalmic solution

Group Type ACTIVE_COMPARATOR

Low Dose - SkQ1

Intervention Type DRUG

SkQ1 Low dose ophthalmic solution

High Dose - SkQ1

High-dose ophthalmic solution

Group Type ACTIVE_COMPARATOR

High dose - SkQ1

Intervention Type DRUG

SkQ1 High Dose ophthalmic solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Low Dose - SkQ1

SkQ1 Low dose ophthalmic solution

Intervention Type DRUG

High dose - SkQ1

SkQ1 High Dose ophthalmic solution

Intervention Type DRUG

SkQ1 (Vehicle)

Vehicle for SkQ1 ophthalmic solution

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Visomitin Visomitin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No