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Completed

NCT Number: NCT01960010

A Safety and Efficacy Study of MIM-D3 Ophthalmic Solution 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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

MIM-725 Investigational Site, Waterbury, Connecticut, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIM-D3 Ophthalmic Solution

Drug

1% MIM-D3 dosed BID

Other names: Tavilermide Ophthalmic Solution

Vehicle

Drug

Vehicle dosed BID

Other names: Placebo Ophthalmic Solution

Primary outcomes

  1. Corneal Fluorescein Staining

    Time frame: Day 29

  2. Ocular Dryness

    Time frame: 28 Days

    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.

Secondary outcomes

  1. Total Ocular Fluorescein Staining

    Time frame: Day 29

  2. Ocular Discomfort

    Time frame: 28 Days

    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.

Other outcomes

  1. Fluorescein staining (Ora CalibraTM Scale)

    Time frame: Day 15, 29 and 57

    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;

  2. Lissamine green staining (Ora CalibraTM Scale,)

    Time frame: Day 15, 29 and 57

    Lissamine green staining (pre and post-CAESM; regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total)

  3. Subject diary individual symptoms

    Time frame: 28-day and 56-day treatment periods

  4. Tear film break-up time

    Time frame: Day 15, 29 and 57

    Tear film break-up time (pre and post-CAESM);

Sponsors and collaborators

Lead sponsor

Mimetogen Pharmaceuticals USA, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 10, 2013
Registry last updated
Aug 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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