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Tavilermide Ophthalmic Solution for the Treatment of Dry Eye | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Multi-Center, Randomized,Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy Study of Tavilermide Ophthalmic Solutions for the Treatment of Dry Eye

NCT03925727•Mimetogen Pharmaceuticals USA, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Subject-reported history of dry eye disease in both eyes for at least 6 months;
•History of use of artificial tear eye drops for dry eye symptoms;
•Total score of ≥40 on SANDE;
•TFBUT;
•Corneal fluorescein staining;
•Lissamine green conjunctival staining;
•Schirmer's test score.

Exclusion Criteria

•Have participated in a previous tavilermide (MIM-D3) study;
•Have clinically significant slit lamp findings at Visit 1;
•Have a history of lacrimal duct obstruction within 12 months of Visit 1;
•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 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 45 days prior to Visit 1.

Locations (22)

Tavilermide Investigational Site

Phoenix, Arizona, United States

Tavilermide Investigational Site

Los Angeles, California, United States

Tavilermide Investigational Site

Newport Beach, California, United States

Tavilermide Investigational Site

Fort Collins, Colorado, United States

Tavilermide Investigational Site

Littleton, Colorado, United States

Tavilermide Investigational Site

Boynton Beach, Florida, United States

Tavilermide Investigational Site

Bradenton, Florida, United States

Tavilermide Investigational Site

Coral Springs, Florida, United States

Tavilermide Investigational Site

Ocala, Florida, United States

Tavilermide Investigational Site

Indianapolis, Indiana, United States

Key Dates

Start Date

March 28, 2019

Primary Completion Date

June 11, 2020

Completion Date

June 11, 2020

Last Updated

April 5, 2023

Enrollment

623

ACTUAL participants

Conditions

Keratoconjunctivitis SiccaDry Eye

Interventions

Tavilermide ophthalmic solution

DRUG

Placebo

OTHER

Sponsors

Lead Sponsor

Mimetogen Pharmaceuticals USA, Inc.

Related Studies

RECRUITINGPHASE4

A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study

NCT07463950

Dry Eye Disease (DED)

A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.

NCT07363824

Dry Eye DiseaseIron

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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