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BETOPTIC S

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 Enrollment105

FDA Designations

No designations recorded

Clinical trial landscape

BETOPTIC S · 1 trial · 2 indications

Phase 3 1
NCT00061542Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular HypertensionGlaucoma
COMPLETED105 Analytics
PHASE3COMPLETED
Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change from baseline in IOP
Up to Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BetaxololEXPERIMENTALTwo doses daily for 12 weeks
TGFS 0.25%EXPERIMENTALTwo doses daily for 12 weeks
TGFS 0.5%EXPERIMENTALTwo doses daily for 12 weeks

Interventions

NameTypeDescription
BETOPTIC S (betaxolol HCl)DRUGbetaxolol HC)
Timolol Gel-forming Solution (TGFS)DRUGtimolol maleate 0.25% and 0.5%
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Eligibility Criteria

Age Range1 Week to 5 Years
SexMALE
Healthy VolunteersNo
Study Sites1

INCLUSION: * Children 5 years old and younger * require treatment for glaucoma or ocular hypertension * whose vision is 20/80 or better * have a 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 kera...

Countries:United States
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Frequently asked questions about BETOPTIC S

What is BETOPTIC S used for?

BETOPTIC S is a small molecule used for the treatment of glaucoma. It is being developed by Alcon Inc. for use in ophthalmology. The drug is currently in Phase 3 clinical development for this indication.

What does BETOPTIC S target?

BETOPTIC S is a small molecule used for glaucoma. Its specific molecular target is not disclosed in the available information. The drug is being developed by Alcon Inc. and is in Phase 3 clinical trials.

Who makes BETOPTIC S?

BETOPTIC S is developed by Alcon Inc., a company traded under the ticker ALC. The drug is a small molecule in Phase 3 clinical development for the treatment of glaucoma.

What phase is BETOPTIC S in?

BETOPTIC S is in Phase 3 clinical development. It is an investigational drug for the treatment of glaucoma and has not been approved by regulatory authorities. The drug is being developed by Alcon Inc.

What clinical trials is BETOPTIC S in?

BETOPTIC S has one completed Phase 3 clinical trial, NCT00061542, which studied the safety and efficacy of BETOPTIC S 0.25% compared with Timolol Gel-forming Solution in pediatric patients with glaucoma or ocular hypertension. The trial enrolled 105 participants in the United States.

Is BETOPTIC S the same as Timolol?

No, BETOPTIC S is not the same as Timolol. BETOPTIC S is a separate drug being developed by Alcon Inc. for glaucoma. In clinical trial NCT00061542, BETOPTIC S 0.25% was studied against Timolol Gel-forming Solution as a comparator.