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

A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

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.

Study Overview

• Status: Completed
• Conditions: Keratoconjunctivitis Sicca
• Intervention / Treatment: Drug: 1% Tavilermide Ophthalmic Solution; Drug: Placebo Ophthalmic Solution

• Study Type: Interventional
• Enrollment (Actual): 429
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States
      • MIM-727 Investigational Site
  • Tennessee
    • Nashville, Tennessee, United States
      • MIM-727 Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Tavilermide Ophthalmic Solution; 1% Tavilermide Ophthalmic Solution	Drug: 1% Tavilermide Ophthalmic Solution; 1% Tavilermide BID Dosing
PLACEBO_COMPARATOR: Vehicle Ophthalmic Solution; Placebo Ophthalmic Solution	Drug: Placebo Ophthalmic Solution; Vehicle Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Corneal Fluorescein Staining	Day 57
Ocular Discomfort	Day 57

Secondary Outcome Measures

Outcome Measure	Time Frame
Ocular Surface Disease Index	Day 57
Corneal Fluorescein Staining	Day 15
Ocular Dryness	8 weeks

Collaborators and Investigators

• Sponsor: Mimetogen Pharmaceuticals USA, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): March 1, 2017

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 17, 2015
• First Posted (ESTIMATE): December 18, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Dry Eye
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: MIM-727