A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye disease.

Official Title
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A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye Disease

Conditions
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Keratoconjunctivitis Sicca

Intervention / Treatment
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* Drug: 1% Tavilermide Ophthalmic Solution
* Drug: Placebo Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age. Provided written informed consent. Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye Exclusion Criteria: Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) at Visit 1. Be diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months. Have any planned ocular and/or lid surgeries over the study period. Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit . 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 known allergy and/or sensitivity to the test article or its components. 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 of Visit 1 Be unable or unwilling to follow instructions, including participation in all study assessments and visits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tavilermide Ophthalmic Solution<br>1% Tavilermide Ophthalmic Solution | Drug: 1% Tavilermide Ophthalmic Solution<br>* 1% Tavilermide BID Dosing<br>|
| Placebo Comparator: Vehicle Ophthalmic Solution<br>Placebo Ophthalmic Solution | Drug: Placebo Ophthalmic Solution<br>* Vehicle Ophthalmic Solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Corneal Fluorescein Staining Using The Ora Calibra Scale | An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE) | Day 57 | 
| Ocular Discomfort Using The Ora Calibra Scale | A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period | Day 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Corneal Fluorescein Staining Using The Ora Calibra Scale | An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE) | Day 15 | 
| Ocular Surface Disease Index |  | Day 57 | 
| Ocular Dryness Using The Ora Calibra Scale | A patient-reported subjective assessment of ocular dryness recorded twice daily over the complete treatment period. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye