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

Mimetogen Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Dry Eye Syndromes

Dry Eye Disease

Kerato Conjunctivitis Sicca

Treatments

Other: Vehicle ophthalmic solution

Drug: 5% Tavilermide ophthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT05848128

MIM-729

Details and patient eligibility

About

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.

Enrollment

642 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.