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A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye

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ClinicalTrials.gov Identifier: NCT02634853
Recruitment Status : Completed
First Posted : December 18, 2015
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mimetogen Pharmaceuticals USA, Inc.

Brief Summary:
The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Drug: 1% Tavilermide Ophthalmic Solution Drug: Placebo Ophthalmic Solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 429 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
Study Start Date : December 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Active Comparator: Tavilermide Ophthalmic Solution
1% Tavilermide Ophthalmic Solution
Drug: 1% Tavilermide Ophthalmic Solution
1% Tavilermide BID Dosing

Placebo Comparator: Vehicle Ophthalmic Solution
Placebo Ophthalmic Solution
Drug: Placebo Ophthalmic Solution
Vehicle Ophthalmic Solution




Primary Outcome Measures :
  1. Corneal Fluorescein Staining [ Time Frame: Day 57 ]
  2. Ocular Discomfort [ Time Frame: Day 57 ]

Secondary Outcome Measures :
  1. Corneal Fluorescein Staining [ Time Frame: Day 15 ]
  2. Ocular Surface Disease Index [ Time Frame: Day 57 ]
  3. Ocular Dryness [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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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:

Be at least 18 years of age Provided written informed consent Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye

Exclusion Criteria:

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 Have any planned ocular and/or lid surgeries over the study period 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 Have an uncontrolled systemic disease Be a woman who is pregnant, nursing or planning a pregnancy 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 Have a known allergy and/or sensitivity to the test article or its components 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 Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days of Visit 1 Be unable or unwilling to follow instructions, including participation in all study assessments and visits


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): NCT02634853


Locations
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United States, Kentucky
MIM-727 Investigational Site
Louisville, Kentucky, United States
United States, Tennessee
MIM-727 Investigational Site
Nashville, Tennessee, United States
Sponsors and Collaborators
Mimetogen Pharmaceuticals USA, Inc.
Investigators
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Study Director: Garth Cumberlidge, PhD Mimetogen Pharmaceuticals USA, Inc.

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Responsible Party: Mimetogen Pharmaceuticals USA, Inc.
ClinicalTrials.gov Identifier: NCT02634853     History of Changes
Other Study ID Numbers: MIM-727
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Keywords provided by Mimetogen Pharmaceuticals USA, Inc.:
Dry Eye
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions