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Ecabet

Phase 2

Dry Eye Syndromes | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Sep 3, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment162

FDA Designations

No designations recorded

Clinical trial landscape

Ecabet · 2 trials · 2 indications

Phase 2 2
NCT00667004Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye DiseaseDry Eye Disease
COMPLETED183 Analytics
NCT00370747Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye SyndromeDry Eye Syndromes
COMPLETED162 Analytics
PHASE2COMPLETED
Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease
Dry Eye DiseaseUnlock trial analytics
PHASE2COMPLETED
Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome
Dry Eye SyndromesUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Change From Baseline in Lacrimation Assessed by Schirmer's Test
43 days

The Schirmer's test is used determine if tear glands produce enough tears to keep eyes adequately moist. Calibrated strips of a non-toxic filter paper are used. One free end is placed within the lower eyelid. At the conclusion of the test, the paper strip is removed from the lower eyelid and the amount of wetting of the paper strip is measured.

Ocular signs and Symptoms
90 days

ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate, and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, photophobia, photopsia, and eye discomfort

Secondary Endpoints

Ocular Surface Disease Index (OSDI)
90 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALecabet ophthalmic solution
2PLACEBO_COMPARATORPlacebo comparator
EcabetEXPERIMENTALOphthalmic solution in the Study eye four times daily for 90 days.
PlaceboPLACEBO_COMPARATOROphthalmic solution in the Study eye four times daily for 90 days.

Interventions

NameTypeDescription
ecabet ophthalmic solutionDRUGsterile ophthalmic solution
placeboDRUGsterile ophthalmic solution
EcabetDRUGophthalmic solution 2.83%
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Eligibility Criteria

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

Inclusion Criteria: * Diagnosed with dry eye disease Exclusion Criteria: * Dry eye disease secondary to surgery

Countries:United States
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Frequently asked questions about Ecabet

What is Ecabet used for?

Ecabet is an investigational small molecule being developed for the treatment of dry eye disease and dry eye syndromes. It is formulated as an ophthalmic solution and is currently in clinical development for these ophthalmology indications.

Who makes Ecabet?

Ecabet is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker symbol BLCO. The company is conducting clinical trials to evaluate the safety and efficacy of Ecabet ophthalmic solution.

What phase is Ecabet in?

Ecabet is in Phase 2 clinical development. Two Phase 2 trials have been completed for the treatment of dry eye disease and dry eye syndromes. The drug is investigational and has not yet been approved by regulatory authorities.

What clinical trials is Ecabet in?

Ecabet has been studied in two completed Phase 2 clinical trials. NCT00370747 evaluated Ecabet ophthalmic solution for treating dry eye syndrome with 162 participants, and NCT00667004 evaluated Ecabet in dry eye disease with 183 participants. Both trials were conducted in the United States.

Is Ecabet the same as any other drug?

Ecabet is also known by its chemical name ecabet sodium. In clinical trials, it is referred to as Ecabet ophthalmic solution. No other alternative names have been associated with this drug in the available clinical trial information.