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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.
 
ClinicalTrials.gov Identifier: NCT01257607
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Mimetogen Pharmaceuticals USA, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Drug: MIM-D3 Ophthalmic Solution Drug: Placebo Ophthalmic Solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011
Arms and Interventions
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Arm Intervention/treatment
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: Placebo Ophthalmic Solution
28 Days, BID


Outcome Measures
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Primary Outcome Measures :
  1. Corneal staining [ Time Frame: 28 days ]
    Ocular surface damage


Secondary Outcome Measures :
  1. Tear film break-up time [ Time Frame: 42 days ]
  2. Conjunctival redness [ Time Frame: 42 days ]
  3. Tear osmolarity [ Time Frame: 42 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01257607


Locations
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United States, Massachusetts
Ora, Inc.
Andover, Massachusetts, United States, 01830
Sponsors and Collaborators
Mimetogen Pharmaceuticals USA, Inc.
Investigators
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Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
Principal Investigator: John Lonsdale, MD Central Maine Eye Care
More Information
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Responsible Party: Mimetogen Pharmaceuticals USA, Inc.
ClinicalTrials.gov Identifier: NCT01257607    
Other Study ID Numbers: MIM-724
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
 Conjunctival Diseases
Keratitis
Corneal Diseases
Pharmaceutical Solutions
Ophthalmic Solutions