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

Alcon

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Timolol Gel-forming Solution (TGFS); Drug: BETOPTIC S (betaxolol HCl)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00061542

C-01-01

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of BETOPTIC S and Timolol Gel-forming solution 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: 105 patients

Sex: Male

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
• 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 keratoplasty
• severe ocular pathology
• optic atrophy
• eye surgery in the past 30 days
• cardiovascular abnormalities
• hypersensitivity to beta blockers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups

Betaxolol

Experimental group

Description:

Two doses daily for 12 weeks

Treatment:

Drug: BETOPTIC S (betaxolol HCl)

TGFS 0.25%

Experimental group

Description:

Two doses daily for 12 weeks

Treatment:

Drug: Timolol Gel-forming Solution (TGFS)

TGFS 0.5%

Experimental group

Description:

Two doses daily for 12 weeks

Treatment:

Drug: Timolol Gel-forming Solution (TGFS)