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

Phase 3

Completed

Interventions: Drug: Placebo Ophthalmic Solution
Drug: 1% Tavilermide Ophthalmic Solution

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Vehicle Ophthalmic Solution	Placebo Ophthalmic Solution	Placebo Ophthalmic Solution
Tavilermide Ophthalmic Solution	1% Tavilermide Ophthalmic Solution	1% Tavilermide Ophthalmic Solution

Primary Outcome Measures

Name	Time	Method
Ocular Discomfort Using The Ora Calibra Scale	Day 57	A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period
Total Corneal Fluorescein Staining Using The Ora Calibra Scale	Day 57	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)

Secondary Outcome Measures

Name	Time	Method
Total Corneal Fluorescein Staining Using The Ora Calibra Scale	Day 15	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)
Ocular Surface Disease Index	Day 57
Ocular Dryness Using The Ora Calibra Scale	8 weeks	A patient-reported subjective assessment of ocular dryness recorded twice daily over the complete treatment period.