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

Last updated: August 15, 2019
Sponsor: Mimetogen Pharmaceuticals USA, Inc.
Overall Status: Completed

Phase

3

Condition

Eyelid Inflammation

Sjogren's Syndrome

Dry Eye Disease

Treatment

N/A

Clinical Study ID

NCT01960010
MIM-725
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or activeocular inflammation (e.g. follicular conjunctivitis) at Visit 1, or have beendiagnosed with ocular rosacea, or any viral or bacterial disease of the cornea orconjunctiva, 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 EarlyTreatment 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 birthcontrol; acceptable methods of contraception include: hormonal - oral, implantable,injectable, or transdermal contraceptives; mechanical - spermicide in conjunction witha 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 ofbirth control; however, if the subject becomes sexually active during the study, shemust agree to use adequate birth control as defined above for the remainder of thestudy

  • 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 subjectat significant risk, may confound the study results, or may interfere significantlywith the subject's participation in the study

  • Be currently enrolled in an investigational drug or device study or have used aninvestigational drug or device within 45 days of Visit 1

  • Be unable or unwilling to follow instructions, including participation in all studyassessments and visits

Study Design

Total Participants: 403
Study Start date:
October 01, 2013
Estimated Completion Date:
August 31, 2014

Connect with a study center

  • MIM-725 Investigational Site

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • MIM-725 Investigational Site

    Lewiston, Maine 04240
    United States

    Site Not Available

  • MIM-725 Investigational Site

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • MIM-725 Investigational Site

    Quincy, Massachusetts 02169
    United States

    Site Not Available

  • MIM-725 Investigational Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.