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BETAXON

Phase 3FDA approved 2000

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

BETAXON development status

FDA approval Feb 23, 2000
Approval holderAlcon Pharms Ltd
ApplicationNDA021114
Highest phase Phase 3

BETAXON target and mechanism

ModalitySmall molecule

Also known as BETAXON (levobetaxolol HCl)

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

BETAXON clinical trials

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?

BETAXON is an ophthalmology medicine being studied for the treatment of glaucoma and ocular hypertension. It is a small molecule product developed by Alcon Inc. (ticker ALC). Its clinical development has focused on use in pediatric patients with these eye conditions.

Who makes BETAXON?

BETAXON is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor behind the clinical program evaluating BETAXON in patients with glaucoma or ocular hypertension.

What phase is BETAXON in?

BETAXON is in Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently listed as active. The completed study was randomized, double blind, and controlled, enrolling 78 participants.

What clinical trials is BETAXON in?

BETAXON has been evaluated in the Phase 3 trial NCT00061516, titled Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension. The trial is completed, enrolled 78 participants, and included patients as young as 1 week old.

Is BETAXON the same as levobetaxolol HCl?

Yes. BETAXON is also known as BETAXON (levobetaxolol HCl), so the two names refer to the same product. Levobetaxolol HCl is the chemical form of the small molecule developed by Alcon Inc. for glaucoma and ocular hypertension.