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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.

Tracking Information
First Submitted Date  ICMJE December 7, 2010
First Posted Date  ICMJE December 9, 2010
Last Update Posted Date August 19, 2019
Study Start Date  ICMJE November 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2010)
Corneal staining [ Time Frame: 28 days ]
Ocular surface damage
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01257607 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2010)
  • Tear film break-up time [ Time Frame: 42 days ]
  • Conjunctival redness [ Time Frame: 42 days ]
  • Tear osmolarity [ Time Frame: 42 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of MIM-D3 Ophthalmic Solution for the Treatment of Dry Eye
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE
  • Drug: MIM-D3 Ophthalmic Solution
    28 Days, BID
  • Drug: Placebo Ophthalmic Solution
    28 Days, BID
Study Arms  ICMJE
  • 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: Placebo Ophthalmic Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2010)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01257607
Other Study ID Numbers  ICMJE MIM-724
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mimetogen Pharmaceuticals USA, Inc.
Study Sponsor  ICMJE Mimetogen Pharmaceuticals USA, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
Principal Investigator: John Lonsdale, MD Central Maine Eye Care
PRS Account Mimetogen Pharmaceuticals USA, Inc.
Verification Date August 2019

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