Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Mimetogen Pharmaceuticals USA, Inc.623 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

623

Conditions

Keratoconjunctivitis Sicca Dry Eye

Interventions

Tavilermide ophthalmic solutionDRUG

BID topical dosing

PlaceboOTHER

BID topical dosing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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.

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

Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale

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.

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

Data from ClinicalTrials.gov

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