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Ecabet

Phase 2

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

Ecabet development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Sep 2006

Ecabet target and mechanism

ModalitySmall molecule

Also known as ecabet ophthalmic solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment345

FDA Designations

No designations recorded

Ecabet clinical trials

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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Competitive Landscape -Dry Eye Disease 8 trials

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Frequently asked questions about Ecabet

What is Ecabet used for?

Ecabet is being developed for Dry Eye Disease and Dry Eye Syndromes. It is an ophthalmic solution intended for topical use in the eye. The clinical program has focused on evaluating its efficacy in treating these tear film and ocular surface conditions.

Who makes Ecabet?

Ecabet is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is responsible for the clinical development of the ecabet ophthalmic solution for dry eye indications.

What phase is Ecabet in?

Ecabet is in Phase 2 clinical development. It has not been approved by the FDA and remains an investigational product. The completed Phase 2 trials were designed to assess efficacy and safety in patients with dry eye conditions.

What clinical trials is Ecabet in?

Ecabet has been studied in two completed Phase 2 trials: NCT00667004, titled Efficacy Study of Ecabet Ophthalmic Solution in Dry Eye Disease, and NCT00370747, titled Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome. Both were conducted in the United States.

Is Ecabet the same as ecabet ophthalmic solution?

Yes, ecabet ophthalmic solution is another name for Ecabet. The term refers to the same investigational product developed by Bausch + Lomb for dry eye indications. Searches for either name refer to the same clinical program.

How many patients were enrolled in Ecabet trials?

The two completed Phase 2 trials of Ecabet enrolled a combined total of 345 patients. NCT00667004 enrolled 183 participants, and NCT00370747 enrolled 162 participants. Both studies were randomized, double-blind, and placebo-controlled, and included adults aged 18 years and older.