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1% Tavilermide

Phase 3

Keratoconjunctivitis Sicca | Small molecule | Ophthalmology |BrainsWay Ltd.|Last Updated: Aug 16, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

Clinical trial landscape

1% Tavilermide · 1 trial · 1 indication

Phase 3 1
NCT02665234A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye DiseaseKeratoconjunctivitis Sicca
COMPLETED400 Analytics
PHASE3COMPLETED
A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease
Keratoconjunctivitis SiccaUnlock trial analytics

Study Endpoints

Primary Endpoints

Total Corneal Fluorescein Staining Using The Ora Calibra Scale
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)

Ocular Discomfort Using The Ora Calibra Scale
Day 57

A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period

Secondary Endpoints

Total Corneal Fluorescein Staining Using The Ora Calibra Scale
Day 15
Ocular Surface Disease Index
Day 57
Ocular Dryness Using The Ora Calibra Scale
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Tavilermide Ophthalmic SolutionACTIVE_COMPARATOR1% Tavilermide Ophthalmic Solution
Vehicle Ophthalmic SolutionPLACEBO_COMPARATORPlacebo Ophthalmic Solution

Interventions

NameTypeDescription
1% Tavilermide Ophthalmic SolutionDRUG1% Tavilermide BID Dosing
Placebo Ophthalmic SolutionDRUGVehicle Ophthalmic Solution
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

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. *...

Countries:United States
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Frequently asked questions about 1% Tavilermide

What is 1% Tavilermide used for?

1% Tavilermide is an investigational small molecule being studied for the treatment of Keratoconjunctivitis Sicca, commonly known as dry eye disease. It is formulated as an ophthalmic solution and is currently in Phase 3 clinical development. The drug is not yet approved and remains under investigation for this condition.

What does 1% Tavilermide target?

1% Tavilermide is a small molecule ophthalmic solution being developed for dry eye disease. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated for safety and efficacy in patients with Keratoconjunctivitis Sicca.

Who makes 1% Tavilermide?

1% Tavilermide is being developed by BrainsWay Ltd., a company traded under the ticker symbol BWAY. The drug is in Phase 3 clinical development for the treatment of Keratoconjunctivitis Sicca, also known as dry eye disease. BrainsWay is conducting clinical trials to evaluate its safety and efficacy.

What phase is 1% Tavilermide in?

1% Tavilermide is in Phase 3 clinical development for the treatment of Keratoconjunctivitis Sicca, or dry eye disease. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 clinical trial has been completed to evaluate its safety and efficacy in this condition.

What clinical trials is 1% Tavilermide in?

1% Tavilermide has one completed Phase 3 clinical trial registered under NCT02665234. This study, titled 'A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease,' enrolled 400 participants in the United States. The trial was randomized, double-blind, and placebo-controlled, and included biomarker-selected patients.

Is 1% Tavilermide the same as MIM-D3?

Yes, 1% Tavilermide is also known as MIM-D3. The clinical trial NCT02665234 refers to the drug as 'Tavilermide (MIM-D3) Ophthalmic Solution.' This alternative name may be used in scientific literature and clinical trial registrations for the same investigational treatment for dry eye disease.