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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01960010
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : August 26, 2014
Information provided by (Responsible Party):
Mimetogen Pharmaceuticals USA, Inc.

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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: MIM-D3 Ophthalmic Solution Drug: Vehicle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : October 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Active Comparator: 1% MIM-D3
1% MIM-D3 Ophthalmic Solution
Drug: MIM-D3 Ophthalmic Solution
1% MIM-D3 dosed BID
Other Name: 1% MIM-D3

Placebo Comparator: Vehicle
Drug: Vehicle
Vehicle dosed BID
Other Name: Placebo Ophthalmic Solution

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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);

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01960010

United States, Connecticut
MIM-725 Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Maine
MIM-725 Investigational Site
Lewiston, Maine, United States, 04240
United States, Massachusetts
MIM-725 Investigational Site
Andover, Massachusetts, United States, 01810
MIM-725 Investigational Site
Quincy, Massachusetts, United States, 02169
United States, Tennessee
MIM-725 Investigational Site
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
Mimetogen Pharmaceuticals USA, Inc.
Study Director: Garth Cumberlidge, PhD Mimetogen Pharmaceuticals USA, Inc.

Responsible Party: Mimetogen Pharmaceuticals USA, Inc. Identifier: NCT01960010     History of Changes
Other Study ID Numbers: MIM-725
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: August 26, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions