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

A Phase 3, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1% MIM-D3 Ophthalmic Solution in the Environment, and During Challenge in the Controlled Adverse Environmental (CAE) Model for the Treatment of Dry Eye

The purpose of this study is to assess the safety and efficacy of MIM-D3 Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: MIM-D3 Ophthalmic Solution; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • MIM-725 Investigational Site
  • Maine
    • Lewiston, Maine, United States, 04240
      • MIM-725 Investigational Site
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • MIM-725 Investigational Site
    • Quincy, Massachusetts, United States, 02169
      • MIM-725 Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • MIM-725 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 Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: Vehicle; Vehicle dosed BID; Other Names: Placebo Ophthalmic Solution
Active Comparator: 1% MIM-D3; 1% MIM-D3 Ophthalmic Solution	Drug: MIM-D3 Ophthalmic Solution; 1% MIM-D3 dosed BID; Other Names: Tavilermide Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Fluorescein Staining		Day 29
Ocular Dryness	Patient-derived, daily dryness symptoms for the 28 day time period will be be averaged to obtain a dryness score for the entire 28-day period. Average dryness scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests.	28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Ocular Fluorescein Staining		Day 29
Ocular Discomfort	Patient-derived daily diary ocular discomfort symptoms for the 28 day time period will be averaged to obtain an ocular discomfort score for the entire 28-day period. Average ocular discomfort scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests.	28 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fluorescein staining (Ora CalibraTM Scale)	Fluorescein Staining, (pre and post-CAESM; by individual region: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total), by both grade and clearance of staining;	Day 15, 29 and 57
Lissamine green staining (Ora CalibraTM Scale,)	Lissamine green staining (pre and post-CAESM; regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total)	Day 15, 29 and 57
Subject diary individual symptoms		28-day and 56-day treatment periods
Tear film break-up time	Tear film break-up time (pre and post-CAESM);	Day 15, 29 and 57

Collaborators and Investigators

• Sponsor: Mimetogen Pharmaceuticals USA, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: October 4, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (Estimate): October 10, 2013

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: MIM-725