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

NCT ID: NCT02665234

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-03-31

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.

Conditions

Keratoconjunctivitis Sicca

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tavilermide Ophthalmic Solution

1% Tavilermide Ophthalmic Solution

Group Type: ACTIVE_COMPARATOR

1% Tavilermide Ophthalmic Solution

Intervention Type: DRUG

1% Tavilermide BID Dosing

Vehicle Ophthalmic Solution

Placebo Ophthalmic Solution

Group Type: PLACEBO_COMPARATOR

Placebo Ophthalmic Solution

Intervention Type: DRUG

Vehicle Ophthalmic Solution

Interventions

1% Tavilermide Ophthalmic Solution

1% Tavilermide BID Dosing

Intervention Type: DRUG

Placebo Ophthalmic Solution

Vehicle Ophthalmic Solution

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mimetogen Pharmaceuticals USA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Garth Cumberlidge, PhD

Role: STUDY_DIRECTOR

Mimetogen Pharmaceuticals USA, Inc.

Locations

MIM-726 Investigational Site

Torrance, California, United States

Countries

United States

Other Identifiers

MIM-726

Identifier Type: -

Identifier Source: org_study_id