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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:
NCT01257607
First received: December 7, 2010
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

The objective of this study is to compare the safety and efficacy of 1% MIM-D3 and 5% MIM-D3 to placebo for the treatment of the signs and symptoms of dry eye.


Condition Intervention Phase
Dry Eye
 Drug: MIM-D3 Ophthalmic Solution
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1% MIM-D3 and 5% MIM-D3 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAE) Model

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Corneal staining [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Ocular surface damage


Secondary Outcome Measures:
  • Tear film break-up time [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Conjunctival redness [ Time Frame: 42 days ] [ Designated as safety issue: No ]
  • Tear osmolarity [ Time Frame: 42 days ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1% MIM-D3 Ophthalmic Solution Drug: MIM-D3 Ophthalmic Solution
28 Days, BID
Experimental: 5% MIM-D3 Ophthalmic Solution Drug: MIM-D3 Ophthalmic Solution
28 Days, BID
Placebo Comparator: Placebo Ophthalmic Solution Drug: MIM-D3 Ophthalmic Solution
28 Days, BID

  Eligibility

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

Inclusion Criteria:

  1. Be at least 18 years of age
  2. Provide written informed consent
  3. Have a reported history of dry eye
  4. Have a history of use or desire to use eye drops for dry eye

Exclusion Criteria:

  1. 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
  2. Have any planned ocular and/or lid surgeries over the study period
  3. 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
  4. Have an uncontrolled systemic disease
  5. Be a woman who is pregnant, nursing or planning a pregnancy
  6. 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
  7. Have a known allergy and/or sensitivity to the test article or its components
  8. 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
  9. Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days of Visit 1
  10. Be unable or unwilling to follow instructions, including participation in all study assessments and visits
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257607

Locations
United States, Massachusetts
Ora, Inc.
Andover, Massachusetts, United States, 01830
Sponsors and Collaborators
Mimetogen Pharmaceuticals USA, Inc.
Investigators
Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
Principal Investigator: John Lonsdale, MD Central Maine Eye Care
  More Information

No publications provided

Responsible Party: Mimetogen Pharmaceuticals USA, Inc.
ClinicalTrials.gov Identifier: NCT01257607     History of Changes
Other Study ID Numbers: MIM-724
Study First Received: December 7, 2010
Last Updated: October 22, 2012
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

ClinicalTrials.gov processed this record on June 17, 2013