Clinical trial
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
Name
MIM-729
Description
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.
Trial arms
Trial start
2023-06-28
Estimated PCD
2024-05-01
Trial end
2024-05-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
5% Tavilermide ophthalmic solution
Twice a day topicial dosing
Arms:
5% Tavilermide ophthalmic solution
Vehicle ophthalmic solution
Twice a day topical dosing
Arms:
Vehicle ophthalmic solution
Size
642
Primary endpoint
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
Baseline to Day 85
Change From Baseline in Eye Dryness Score as Measured by the VAS
Baseline to Day 85
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 642, 'type': 'ACTUAL'}}
Updated at
2024-01-11
1 organization
1 product
2 indications
Product
TavilermideIndication
Dry Eye SyndromeIndication
Keratoconjunctivitis siccaOrganization
Mimetogen Pharmaceuticals USA