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BETAXON

Phase 3

Glaucoma | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Nov 18, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

BETAXON · 1 trial · 2 indications

Phase 3 1
NCT00061516Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular HypertensionGlaucoma
COMPLETED78 Analytics
PHASE3COMPLETED
Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Change from Baseline IOP
Up to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Brinzolamide suspension, 1%EXPERIMENTALDosed twice daily for 12 weeks
Levobetaxolol suspension, 0.5%EXPERIMENTALDosed twice daily for 12 weeks

Interventions

NameTypeDescription
BETAXON (levobetaxolol HCl)DRUGlevobetaxolol suspension, 0.5%
AZOPT (brinzolamide)DRUGbrinzolamide suspension, 1%
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Eligibility Criteria

Age Range1 Week to 5 Years
SexALL
Healthy VolunteersNo

INCLUSION: * Children 5 years old and younger * require treatment for glaucoma or ocular hypertension * vision is 20/80 or better * cup-to-disc ratio of 0.8 or less EXCLUSION: * do not have abnormal fixation * IOP greater than 36 mm Hg * significant retinal disease * penetrating keratoplasty * se...

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Frequently asked questions about BETAXON

What is BETAXON used for in glaucoma?

BETAXON is an investigational small molecule being studied for the treatment of glaucoma and ocular hypertension. It is administered as an ophthalmic solution at a 0.5% concentration. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

What does BETAXON target?

BETAXON is a small molecule developed for ophthalmic use. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated for its safety and efficacy in reducing intraocular pressure in patients with glaucoma or ocular hypertension.

Who makes BETAXON?

BETAXON is being developed by Alcon Inc., a company traded on the New York Stock Exchange under the ticker symbol ALC. Alcon is conducting clinical trials to evaluate the drug's safety and efficacy in pediatric patients with glaucoma or ocular hypertension.

What phase is BETAXON in?

BETAXON is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. The Phase 3 trial has been completed, with results expected to inform further regulatory and development decisions.

What clinical trials is BETAXON in?

BETAXON has one completed Phase 3 clinical trial registered under NCT00061516. This randomized, double-blind, controlled study evaluated the safety and efficacy of BETAXON 0.5% compared to AZOPT 1.0% in 78 pediatric patients with glaucoma or ocular hypertension.

Is BETAXON the same as AZOPT?

BETAXON is not the same as AZOPT. In the clinical trial NCT00061516, BETAXON 0.5% was studied as an active treatment and compared against AZOPT 1.0%, which served as the control. Both are ophthalmic solutions, but they are distinct drug products.