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: NCT01257607
Recruitment Status : Completed
First Posted : December 9, 2010
Last Update Posted : October 23, 2012
Information provided by (Responsible Party):
Mimetogen Pharmaceuticals USA, Inc.

December 7, 2010
December 9, 2010
October 23, 2012
November 2010
May 2011   (Final data collection date for primary outcome measure)
Corneal staining [ Time Frame: 28 days ]
Ocular surface damage
Same as current
Complete list of historical versions of study NCT01257607 on Archive Site
  • Tear film break-up time [ Time Frame: 42 days ]
  • Conjunctival redness [ Time Frame: 42 days ]
  • Tear osmolarity [ Time Frame: 42 days ]
Same as current
Not Provided
Not Provided
Safety and Efficacy Study of MIM-D3 Ophthalmic Solution for the Treatment of Dry Eye
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
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Dry Eye
Drug: MIM-D3 Ophthalmic Solution
28 Days, BID
  • Experimental: 1% MIM-D3 Ophthalmic Solution
    Intervention: Drug: MIM-D3 Ophthalmic Solution
  • Experimental: 5% MIM-D3 Ophthalmic Solution
    Intervention: Drug: MIM-D3 Ophthalmic Solution
  • Placebo Comparator: Placebo Ophthalmic Solution
    Intervention: Drug: MIM-D3 Ophthalmic Solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2011
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Mimetogen Pharmaceuticals USA, Inc.
Mimetogen Pharmaceuticals USA, Inc.
Not Provided
Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
Principal Investigator: John Lonsdale, MD Central Maine Eye Care
Mimetogen Pharmaceuticals USA, Inc.
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP