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

NCT ID: NCT02634853

Last Updated: 2019-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 429 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• 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.

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), 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

• 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-727 Investigational Site

Louisville, Kentucky, United States

MIM-727 Investigational Site

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

MIM-727

Identifier Type: -

Identifier Source: org_study_id