Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

Alcon

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: BETAXON (levobetaxolol HCl); Drug: AZOPT (brinzolamide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00061516

C-00-17

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.

Enrollment: 78 patients

Sex: All

Ages: 1 week to 5 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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
• severe ocular pathology
• optic atrophy
• eye surgery in the past 30 days
• cardiovascular abnormalities
• hypersensitivity to beta blockers, carbonic anhydrase inhibitors or sulfa drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Brinzolamide suspension, 1%

Experimental group

Description:

Dosed twice daily for 12 weeks

Treatment:

Drug: AZOPT (brinzolamide)

Levobetaxolol suspension, 0.5%

Experimental group

Description:

Dosed twice daily for 12 weeks

Treatment:

Drug: BETAXON (levobetaxolol HCl)