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

NCT02634853 | Completed Phase 3

• 1 other identifier: MIM-727
• Study Type: interventional
• Target: 429
• Locations: 1 country
• Sites: 2

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

Keywords

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Corneal Fluorescein Staining

  Day 57

• Ocular Discomfort

  Day 57

Secondary Outcomes (3)

• Corneal Fluorescein Staining

  Day 15

• Ocular Surface Disease Index

  Day 57

• Ocular Dryness

  8 weeks

Study Arms (2)

Tavilermide Ophthalmic Solution

ACTIVE COMPARATOR

1% Tavilermide Ophthalmic Solution

Drug: 1% Tavilermide Ophthalmic Solution

Vehicle Ophthalmic Solution

PLACEBO COMPARATOR

Placebo Ophthalmic Solution

Drug: Placebo Ophthalmic Solution

Interventions

1% Tavilermide Ophthalmic Solution DRUG

1% Tavilermide BID Dosing

Tavilermide Ophthalmic Solution

Placebo Ophthalmic Solution DRUG

Vehicle Ophthalmic Solution

Vehicle Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mimetogen Pharmaceuticals USA, Inc.: lead

Study Sites (2)

MIM-727 Investigational Site

Louisville, Kentucky, United States

Location

MIM-727 Investigational Site

Nashville, Tennessee, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases

Study Officials

• Garth Cumberlidge, PhD

  Mimetogen Pharmaceuticals USA, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 18, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

US (2)