- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02665234
A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease
August 13, 2019 updated by: Mimetogen Pharmaceuticals USA, Inc.
A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye Disease
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Torrance, California, United States
- MIM-726 Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tavilermide Ophthalmic Solution
1% Tavilermide Ophthalmic Solution
|
1% Tavilermide BID Dosing
|
Placebo Comparator: Vehicle Ophthalmic Solution
Placebo Ophthalmic Solution
|
Vehicle Ophthalmic Solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Day 57
|
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
|
Day 57
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Day 15
|
Ocular Surface Disease Index
Time Frame: Day 57
|
Day 57
|
|
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.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
January 20, 2016
First Submitted That Met QC Criteria
January 22, 2016
First Posted (Estimate)
January 27, 2016
Study Record Updates
Last Update Posted (Actual)
August 16, 2019
Last Update Submitted That Met QC Criteria
August 13, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MIM-726
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Keratoconjunctivitis Sicca
-
Karolinska InstitutetKällmark ClinicCompletedKeratoconjunctivitis Sicca (KCS)Sweden
-
Kala Pharmaceuticals, Inc.CompletedKerato Conjunctivitis SiccaUnited States
-
Oyster Point Pharma, Inc.Active, not recruitingDry Eye | Kerato Conjunctivitis SiccaUnited States
-
Meir Medical CenterUnknownHealthy Subjects | Moderate to Severe Keratoconjunctivitis Sicca (KCS) | Dry Eye Syndrome (DES)
-
Glaukos CorporationCompletedDry Eye Disease | Kerato Conjunctivitis SiccaUnited States
-
C.O.C. Farmaceutici S.r.l.CompletedDry Eye | Dry Eye Disease | Kerato Conjunctivitis SiccaItaly
-
C.O.C. Farmaceutici S.r.l.CompletedDry Eye | Dry Eye Disease | Kerato Conjunctivitis SiccaItaly
-
Mimetogen Pharmaceuticals USA, Inc.Active, not recruitingDry Eye Syndromes | Dry Eye Disease | Kerato Conjunctivitis SiccaUnited States
-
C.O.C. Farmaceutici S.r.l.CompletedDry Eye | Dry Eye Disease | Kerato Conjunctivitis SiccaItaly
-
C.O.C. Farmaceutici S.r.l.CompletedDry Eye | Dry Eye Disease | Kerato Conjunctivitis SiccaItaly
Clinical Trials on 1% Tavilermide Ophthalmic Solution
-
Mimetogen Pharmaceuticals USA, Inc.CompletedA Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry EyeKeratoconjunctivitis SiccaUnited States
-
Mimetogen Pharmaceuticals USA, Inc.CompletedDry Eye SyndromesUnited States
-
Mimetogen Pharmaceuticals USA, Inc.Active, not recruitingDry Eye Syndromes | Dry Eye Disease | Kerato Conjunctivitis SiccaUnited States
-
Mimetogen Pharmaceuticals USA, Inc.CompletedDry Eye | Keratoconjunctivitis SiccaUnited States
-
Iacta PharmaceuticalsRecruitingDry Eye SyndromesUnited States
-
Yuyu Pharma, Inc.Active, not recruiting
-
VivaVision Biotech, IncCompleted
-
AllerganCompletedOcular Hypertension | GlaucomaUnited States
-
MacuCLEAR, Inc.UnknownNon-Exudative Age Related Macular DegenerationUnited States
-
Stealth BioTherapeutics Inc.CompletedLeber's Hereditary Optic NeuropathyUnited States