Clinical trial
Multi-Center, Randomized,Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy Study of Tavilermide Ophthalmic Solutions for the Treatment of Dry Eye
Name
MIM-728
Description
The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye.
Trial arms
Trial start
2019-03-28
Estimated PCD
2020-06-11
Trial end
2020-06-11
Status
Completed
Phase
Early phase I
Treatment
Tavilermide ophthalmic solution
BID topical dosing
Arms:
1% Tavilermide ophthalmic solution, 5% Tavilermide ophthalmic solution
Placebo
BID topical dosing
Arms:
Vehicle ophthalmic solution
Size
623
Primary endpoint
Change From Baseline in Eye Dryness Score as Measured by the VAS
Baseline to Day 85 in 5% Tavilermide versus Placebo
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
Baseline to Day 85 in 5% Tavilermide versus Placebo
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': 623, 'type': 'ACTUAL'}}
Updated at
2023-04-05
1 organization
1 product
2 indications
Organization
Mimetogen Pharmaceuticals USAProduct
TavilermideIndication
Dry Eye SyndromeIndication
Dry Eye