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loteprednol etabonate, 0.5%

Phase 2

Dry Eye | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Jul 18, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment119

FDA Designations

No designations recorded

Clinical trial landscape

loteprednol etabonate, 0.5% · 1 trial · 1 indication

Phase 2 1
NCT00560638Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry EyeDry Eye
COMPLETED119 Analytics
PHASE2COMPLETED
Loteprednol Etabonate Opthalmic Suspension for the Treatment of Dry Eye
Dry EyeUnlock trial analytics

Study Endpoints

Primary Endpoints

Ocular discomfort during CAE exposure
during CAE exposure
Corneal and conjunctival staining and conjunctival redness
After CAE exposure

Secondary Endpoints

Corneal and conjunctival staining and conjunctival redness
before CAE exposure
Blink rate, Tear film break-up time (TFBUT), and Ocular Protection Index (OPI)
before after CAE exposure
Ocular discomfort
collected in patient diaries
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Loteprednol Etabonate TIDEXPERIMENTALloteprednol etabonate ophthalmic suspension, 0.5%, TID
Loteprednol Etabonate QIDEXPERIMENTALloteprednol etabonate ophthalmic suspension, 0.5%, QID
VehiclePLACEBO_COMPARATORvehicle of loteprednol etabonate

Interventions

NameTypeDescription
loteprednol etabonate ophthalmic suspension, 0.5%DRUGTID
vehicle of loteprednol etabonateDRUGTID or BID according to the randomization
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Eligibility Criteria

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

Inclusion Criteria: * at least 18 years of age or older * able and willing to follow instructions, including participation in study assessments and able be present for the required study visits for the duration of the study * If female and of childbearing potential, were not pregnant, nursing, or p...

Countries:United States
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Frequently asked questions about loteprednol etabonate, 0.5%

What is Loteprednol Etabonate used for?

Loteprednol Etabonate is a small molecule being developed for ocular conditions including cataract, dry eye, inflammation, ocular inflammation, and seasonal allergic conjunctivitis. It is an investigational drug in clinical development, studied in completed trials for these indications.

Who makes Loteprednol Etabonate?

Loteprednol Etabonate is developed by Bausch + Lomb Corporation, traded on the New York Stock Exchange under the ticker BLCO. The company is conducting clinical research on this ophthalmic drug candidate.

What phase is Loteprednol Etabonate in?

Loteprednol Etabonate is in Phase 1 development, though its completed clinical trials include Phase 2 and Phase 3 studies. It is an investigational drug, not yet approved, and remains in clinical development for ocular indications.

What clinical trials is Loteprednol Etabonate in?

Loteprednol Etabonate has completed three trials: NCT00560638 for dry eye, NCT00699153 for ocular inflammation after cataract surgery, and NCT01435460 for seasonal allergic conjunctivitis. A fourth trial, NCT01475643, studied it for intraocular inflammation following cataract surgery in children.

What does Loteprednol Etabonate target?

Loteprednol Etabonate is a corticosteroid, but its specific molecular target is not disclosed in available data. It is being studied for its anti-inflammatory effects in ocular conditions such as inflammation and allergic conjunctivitis.