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Trial record 2 of 6 for:    calibra

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

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: NCT02665234
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 disease.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 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 Disease
Study Start Date : January 2016
Primary Completion Date : February 2017
Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Total Corneal Fluorescein Staining Using The Ora Calibra Scale [ Time Frame: Day 57 ]
    An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE)

  2. Ocular Discomfort Using The Ora Calibra Scale [ Time Frame: Day 57 ]
    A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period


Secondary Outcome Measures :
  1. Total Corneal Fluorescein Staining Using The Ora Calibra Scale [ Time Frame: Day 15 ]
    An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE)

  2. Ocular Surface Disease Index [ Time Frame: Day 57 ]
  3. Ocular Dryness Using The Ora Calibra Scale [ Time Frame: 8 weeks ]
    A patient-reported subjective assessment of ocular dryness recorded twice daily over the complete treatment period.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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) at Visit 1.
  • Be 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 .
  • 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 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
Contacts and Locations

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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): NCT02665234


Locations
United States, California
MIM-726 Investigational Site
Torrance, California, United States
Sponsors and Collaborators
Mimetogen Pharmaceuticals USA, Inc.
Investigators
Study Director: Garth Cumberlidge, PhD Mimetogen Pharmaceuticals USA, Inc.
More Information

Responsible Party: Mimetogen Pharmaceuticals USA, Inc.
ClinicalTrials.gov Identifier: NCT02665234     History of Changes
Other Study ID Numbers: MIM-726
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mimetogen Pharmaceuticals USA, Inc.:
Dry Eye

Additional relevant MeSH terms:
Eye Diseases
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions
Ophthalmic Solutions