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

Mimetogen Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Keratoconjunctivitis Sicca

Treatments: Drug: Placebo Ophthalmic Solution; Drug: 1% Tavilermide Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02665234

MIM-726

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

Tavilermide Ophthalmic Solution

Active Comparator group

Description:

1% Tavilermide Ophthalmic Solution

Treatment:

Drug: 1% Tavilermide Ophthalmic Solution

Vehicle Ophthalmic Solution

Placebo Comparator group

Description:

Placebo Ophthalmic Solution

Treatment:

Drug: Placebo Ophthalmic Solution