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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mimetogen Pharmaceuticals USA, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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.