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Trial record 3 of 4 for:    tavilermide

Tavilermide 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03925727
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : February 5, 2020
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 5% tavilermide and 1% tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye.

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Dry Eye Drug: tavilermide ophthalmic solution Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Center, Randomized,Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy Study of Tavilermide Ophthalmic Solutions for the Treatment of Dry Eye
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: 1% tavilermide ophthalmic solution Drug: tavilermide ophthalmic solution
BID topical dosing

Experimental: 5% tavilermide ophthalmic solution Drug: tavilermide ophthalmic solution
BID topical dosing

Placebo Comparator: Vehicle ophthalmic solution Other: Placebo
BID topical dosing




Primary Outcome Measures :
  1. Change from baseline in Eye Dryness Score (VAS) [ Time Frame: Day 85 ]
  2. Change from baseline in total Corneal Fluorescein Staining [ Time Frame: Day 85 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject-reported history of dry eye disease in both eyes for at least 6 months;
  • History of use of artificial tear eye drops for dry eye symptoms;
  • Total score of ≥40 on SANDE;
  • TFBUT;
  • Corneal fluorescein staining;
  • Lissamine green conjunctival staining;
  • Schirmer's test score.

Exclusion Criteria:

  • Have participated in a previous tavilermide (MIM-D3) study;
  • Have clinically significant slit lamp findings at Visit 1;
  • Have a history of lacrimal duct obstruction within 12 months of 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;
  • 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 prior to Visit 1.

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): NCT03925727


Contacts
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Contact: Project Manager 1-617-680-6965 rjohnson@oraclinical.com

Locations
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United States, Arizona
Tavilermide Investigational Site Recruiting
Phoenix, Arizona, United States, 85032
United States, California
Tavilermide Investigational Site Recruiting
Los Angeles, California, United States, 90013
Tavilermide Investigational Site Recruiting
Newport Beach, California, United States, 92663
United States, Colorado
Tavilermide Investigational Site Recruiting
Fort Collins, Colorado, United States, 80528
Tavilermide Investigational Site Recruiting
Littleton, Colorado, United States, 80120
United States, Florida
Tavilermide Investigational Site Recruiting
Boynton Beach, Florida, United States, 33437
Tavilermide Investigational Site Recruiting
Bradenton, Florida, United States, 34209
Tavilermide Investigational Site Recruiting
Coral Springs, Florida, United States, 33067
Tavilermide Investigational Site Recruiting
Ocala, Florida, United States, 34474
United States, Indiana
Tavilermide Investigational Site Recruiting
Indianapolis, Indiana, United States, 46290
United States, Iowa
Tavilermide Investigational Site Recruiting
Sioux City, Iowa, United States, 51104
United States, Kentucky
Tavilermide Investigational Site Recruiting
Lexington, Kentucky, United States, 40509
Tavilermide Investigational Site Recruiting
Louisville, Kentucky, United States, 40206
United States, Missouri
Tavilermide Investigational Site Recruiting
Saint Louis, Missouri, United States, 63131
United States, North Carolina
Tavilermide Investigational Site Recruiting
Shelby, North Carolina, United States, 28150
United States, Ohio
Tavilermide Investigational Site Recruiting
Cincinnati, Ohio, United States, 45236
Tavilermide Investigational Site Recruiting
Mason, Ohio, United States, 45040
United States, South Dakota
Tavilermide Investigational Site Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Tavilermide Investigational Site Recruiting
Maryville, Tennessee, United States, 37803
Tavilermide Investigational Site Recruiting
Nashville, Tennessee, United States, 37205
United States, Texas
Tavilermide Investigational Site Recruiting
San Antonio, Texas, United States, 78248
United States, Wisconsin
Tavilermide Investigational Site Recruiting
Kenosha, Wisconsin, United States, 53142
Sponsors and Collaborators
Mimetogen Pharmaceuticals USA, Inc.
Investigators
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Study Director: Karen Meerovitch, PhD Mimetogen Pharmaceuticals

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Responsible Party: Mimetogen Pharmaceuticals USA, Inc.
ClinicalTrials.gov Identifier: NCT03925727    
Other Study ID Numbers: MIM-728
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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