Recent Updates
Recently added Catalysts

ESBA105

Phase 2

Eyes Dry Chronic | Monoclonal antibody | Ophthalmology |Alcon Inc.|Last Updated: Apr 19, 2013

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment334

FDA Designations

No designations recorded

Clinical trial landscape

ESBA105 · 1 trial · 1 indication

Phase 2 1
NCT01338610ESBA105 in Patients With Severe Dry EyeEyes Dry Chronic
COMPLETED334 Analytics
PHASE2COMPLETED
ESBA105 in Patients With Severe Dry Eye
Eyes Dry ChronicUnlock trial analytics

Study Endpoints

Primary Endpoints

Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28
Up to 28 days

An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).

Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ESBA105EXPERIMENTALESBA105 ophthalmic solution, 1 drop in each eye 3 times per day for 4 weeks
VehiclePLACEBO_COMPARATORESBA105 vehicle, 1 drop in each eye 3 times per day for 4 weeks

Interventions

NameTypeDescription
ESBA105 ophthalmic solutionBIOLOGICAL -
ESBA105 vehicleOTHERInactive ingredients used as Run-In and placebo comparator
Unlock Study Design Details

Eligibility Criteria

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

Inclusion Criteria: * Ongoing physician diagnosis of dry eye for at least 6 months. * Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis. * Experience persistent ocular discomfort. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * Contact ...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about ESBA105

What is ESBA105 used for?

ESBA105 is an investigational monoclonal antibody being developed for chronic dry eye, a condition of the eyes. It is administered to patients with severe dry eye. The drug is currently in clinical development and has not been approved by the FDA.

What does ESBA105 target?

ESBA105 is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being studied for its potential to treat chronic dry eye, a condition characterized by insufficient tear production or excessive tear evaporation.

Who makes ESBA105?

ESBA105 is being developed by Alcon Inc., a company traded under the ticker symbol ALC. Alcon is a global medical device company specializing in eye care products, and it is advancing ESBA105 through clinical trials for chronic dry eye.

What phase is ESBA105 in?

ESBA105 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, placebo-controlled study involving 334 patients with severe dry eye. The drug remains investigational and is not yet approved.

What clinical trials is ESBA105 in?

ESBA105 has been studied in one clinical trial, identified as NCT01338610. This Phase 2 trial, titled 'ESBA105 in Patients With Severe Dry Eye,' was completed in the United States. It enrolled 334 participants aged 18 years and older, with no healthy volunteers included.

Is ESBA105 the same as any other drug?

ESBA105 is a distinct investigational monoclonal antibody developed by Alcon Inc. for chronic dry eye. No alternative names for this drug have been reported, and it is not known to be identical to any other approved or investigational medication.