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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mimetogen Pharmaceuticals USA, Inc.
ClinicalTrials.gov Identifier:
NCT01960010
First received: October 4, 2013
Last updated: August 25, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Dry Eye Syndromes
Drug: MIM-D3 Ophthalmic Solution
Drug: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Mimetogen Pharmaceuticals USA, Inc.:

Primary Outcome Measures:
  • Corneal Fluorescein Staining [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Ocular Dryness [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    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:
  • Total Ocular Fluorescein Staining [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Ocular Discomfort [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    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:
  • Fluorescein staining (Ora CalibraTM Scale) [ Time Frame: Day 15, 29 and 57 ] [ Designated as safety issue: No ]
    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;

  • Lissamine green staining (Ora CalibraTM Scale,) [ Time Frame: Day 15, 29 and 57 ] [ Designated as safety issue: No ]
    Lissamine green staining (pre and post-CAESM; regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total)

  • Subject diary individual symptoms [ Time Frame: 28-day and 56-day treatment periods ] [ Designated as safety issue: No ]
  • Tear film break-up time [ Time Frame: Day 15, 29 and 57 ] [ Designated as safety issue: No ]
    Tear film break-up time (pre and post-CAESM);


Enrollment: 403
Study Start Date: October 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Vehicle
Drug: Vehicle
Vehicle dosed BID
Other Name: Placebo Ophthalmic Solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01960010

Locations
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.
Investigators
Study Director: Garth Cumberlidge, PhD Mimetogen Pharmaceuticals USA, Inc.
  More Information

No publications provided

Responsible Party: Mimetogen Pharmaceuticals USA, Inc.
ClinicalTrials.gov Identifier: NCT01960010     History of Changes
Other Study ID Numbers: MIM-725
Study First Received: October 4, 2013
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014