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

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Betaxolol; Pharmaceutical Solutions; Timolol

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