Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

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.

Completed

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Key information

Conditions

Keratoconjunctivitis Sicca Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Lacrimal Apparatus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tavilermide Investigational Site, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tavilermide ophthalmic solution

Drug

BID topical dosing

Placebo

Other

BID topical dosing

Primary outcomes

Change From Baseline in Eye Dryness Score as Measured by the VAS

Time frame: Baseline to Day 85 in 5% Tavilermide versus Placebo

The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm.
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale

Time frame: Baseline to Day 85 in 5% Tavilermide versus Placebo

The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior) . Grade 0 was specified when no staining is present. The maximum score was 15. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.

Sponsors and collaborators

Lead sponsor

Mimetogen Pharmaceuticals USA, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Apr 24, 2019
Registry last updated: Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed