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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

December 7, 2010
October 22, 2012
November 2010
May 2011   (final data collection date for primary outcome measure)
Corneal staining [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Ocular surface damage
Same as current
Complete list of historical versions of study NCT01257607 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01257607
MIM-724
Yes
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