Overview

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.