Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Study Overview
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Brief Summary
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The purpose of the study is to compare the efficacy and safety of 5% tavilermide ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye disease.

Official Title
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A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Clinical Study to Assess the Efficacy and Safety of 5% Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

Conditions
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Dry Eye Syndromes, Dry Eye Disease, Kerato Conjunctivitis Sicca

Intervention / Treatment
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* Drug: 5% Tavilermide ophthalmic solution
* Other: Vehicle ophthalmic solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5% Tavilermide ophthalmic solution<br> | Drug: 5% Tavilermide ophthalmic solution<br>* Twice a day topicial dosing<br>|
| Placebo Comparator: Vehicle ophthalmic solution<br> | Other: Vehicle ophthalmic solution<br>* Twice a day topical dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Day 85 | 
| 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. | Baseline to Day 85 |