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 objective of this study is to compare the safety and efficacy of 1% MIM-D3 and 5% MIM-D3 to placebo for the treatment of the signs and symptoms of dry eye.

Official Title
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A Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1% MIM-D3 and 5% MIM-D3 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAE) Model

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: MIM-D3 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 Provide 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1% MIM-D3 Ophthalmic Solution<br> | Drug: MIM-D3 Ophthalmic Solution<br>* 28 Days, BID<br>|
| Experimental: 5% MIM-D3 Ophthalmic Solution<br> | Drug: MIM-D3 Ophthalmic Solution<br>* 28 Days, BID<br>|
| Placebo Comparator: Placebo Ophthalmic Solution<br> | Drug: Placebo Ophthalmic Solution<br>* 28 Days, BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining | Ocular surface damage | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear film break-up time |  | 42 days | 
| Conjunctival redness |  | 42 days | 
| Tear osmolarity |  | 42 days |