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

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 MIM-D3 Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.

Official Title
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A Phase 3, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1% MIM-D3 Ophthalmic Solution in the Environment, and During Challenge in the Controlled Adverse Environmental (CAE) Model for the Treatment of Dry Eye

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: MIM-D3 Ophthalmic Solution
* Drug: Vehicle


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), or active ocular inflammation (e.g. follicular conjunctivitis) at Visit 1, or have been 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 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; acceptable methods of contraception include: hormonal - oral, implantable, injectable, or transdermal contraceptives; mechanical - spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study 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: 1% MIM-D3<br>1% MIM-D3 Ophthalmic Solution | Drug: MIM-D3 Ophthalmic Solution<br>* 1% MIM-D3 dosed BID<br>* Other names: Tavilermide Ophthalmic Solution;|
| Placebo Comparator: Vehicle<br>Vehicle | Drug: Vehicle<br>* Vehicle dosed BID<br>* Other names: Placebo Ophthalmic Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Fluorescein Staining |  | Day 29 | 
| Ocular Dryness | Patient-derived, daily dryness symptoms for the 28 day time period will be be averaged to obtain a dryness score for the entire 28-day period. Average dryness scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests. | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Ocular Fluorescein Staining |  | Day 29 | 
| Ocular Discomfort | Patient-derived daily diary ocular discomfort symptoms for the 28 day time period will be averaged to obtain an ocular discomfort score for the entire 28-day period. Average ocular discomfort scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests. | 28 Days |