Official Title: “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.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2006

Intervention(s) in this Clinical Trial

• Drug: BETOPTIC S (betaxolol HCl)
• Drug: Timolol Gel-forming Solution (timolol maleate)

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 5 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Alcon Research

Information obtained from ClinicalTrials.gov on November 18, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00061542

Study ID Number: C-01-01

ClinicalTrials.gov Identifier: NCT00061542

Health Authority: United States: Food and Drug Administration