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

• 5% Tavilermide ophthalmic solution (Drug): Twice a day topicial dosing
• Vehicle ophthalmic solution (Other): Twice a day topical dosing

Primary outcomes

• Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale [Baseline to Day 85]: 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.
• Change From Baseline in Eye Dryness Score as Measured by the VAS [Baseline to Day 85]: 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.

Sex: All, ages: 18 Years to any

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.