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

NCT01960010 | Completed Phase 3 DMC

• 1 other identifier: MIM-725
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Total Ocular Fluorescein Staining

  Day 29

• Ocular Discomfort

  28 Days

Other Outcomes (4)

• Fluorescein staining (Ora CalibraTM Scale)

  Day 15, 29 and 57

• Lissamine green staining (Ora CalibraTM Scale,)

  Day 15, 29 and 57

• Subject diary individual symptoms

  28-day and 56-day treatment periods

Study Arms (2)

1% MIM-D3

ACTIVE COMPARATOR

1% MIM-D3 Ophthalmic Solution

Drug: MIM-D3 Ophthalmic Solution

Vehicle

PLACEBO COMPARATOR

Vehicle

Drug: Vehicle

Interventions

MIM-D3 Ophthalmic Solution DRUG

1% MIM-D3 dosed BID

Also known as: Tavilermide Ophthalmic Solution

1% MIM-D3

Vehicle DRUG

Vehicle dosed BID

Also known as: Placebo Ophthalmic Solution

Vehicle

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 (5)

MIM-725 Investigational Site

Waterbury, Connecticut, 06708, United States

Location

MIM-725 Investigational Site

Lewiston, Maine, 04240, United States

Location

MIM-725 Investigational Site

Andover, Massachusetts, 01810, United States

Location

MIM-725 Investigational Site

Quincy, Massachusetts, 02169, United States

Location

MIM-725 Investigational Site

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye 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: October 4, 2013
• First Posted: October 10, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

US (5)