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

Sponsor
Mimetogen Pharmaceuticals USA, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01960010
Collaborator
(none)
403
Enrollment
5
Locations
2
Arms
10
Duration (Months)
80.6
Patients Per Site
8.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
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 :
Oct 1, 2013
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    Placebo Comparator: Vehicle

    Vehicle

    Drug: Vehicle
    Vehicle dosed BID
    Other Names:
  • Placebo Ophthalmic Solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Corneal Fluorescein Staining [Day 29]

    2. Ocular Dryness [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 [Day 29]

    2. Ocular Discomfort [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) [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,) [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 [28-day and 56-day treatment periods]

    4. Tear film break-up time [Day 15, 29 and 57]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MIM-725 Investigational Site Waterbury Connecticut United States 06708
    2 MIM-725 Investigational Site Lewiston Maine United States 04240
    3 MIM-725 Investigational Site Andover Massachusetts United States 01810
    4 MIM-725 Investigational Site Quincy Massachusetts United States 02169
    5 MIM-725 Investigational Site Memphis Tennessee United States 38119

    Sponsors and Collaborators

    • Mimetogen Pharmaceuticals USA, Inc.

    Investigators

    • Study Director: Garth Cumberlidge, PhD, Mimetogen Pharmaceuticals USA, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mimetogen Pharmaceuticals USA, Inc.
    ClinicalTrials.gov Identifier:
    NCT01960010
    Other Study ID Numbers:
    • MIM-725
    First Posted:
    Oct 10, 2013
    Last Update Posted:
    Aug 19, 2019
    Last Verified:
    Aug 1, 2019
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Pharmaceutical Solutions
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Aug 19, 2019