Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 5% Tavilermide ophthalmic solution
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Drug: 5% Tavilermide ophthalmic solution
Twice a day topicial dosing
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Placebo Comparator: Vehicle ophthalmic solution
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Other: Vehicle ophthalmic solution
Twice a day topical dosing
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale [Baseline to Day 85]
The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior). Grade 0 was specified when no staining is present. The maximum score was 15.
- Change From Baseline in Eye Dryness Score as Measured by the VAS [Baseline to Day 85]
The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject-reported history of dry eye disease in both eyes for at least 6 months;
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History of use of artificial tear eye drops for dry eye symptoms;
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Total score of ≥40 on SANDE;
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TFBUT;
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Corneal fluorescein staining;
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Lissamine green conjunctival staining;
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Schirmer's test score.
Exclusion Criteria:
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Have participated in a previous tavilermide (MIM-D3) study;
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Have clinically significant slit lamp findings at Visit 1;
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Have a history of lacrimal duct obstruction within 12 months of Visit 1;
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Have an uncontrolled systemic disease;
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Be a woman who is pregnant, nursing or planning a pregnancy;
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Be a woman of childbearing potential who is not using an acceptable means of birth control;
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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;
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mimetogen Pharmaceuticals USA, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MIM-729