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

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

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.

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.