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

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

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.

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