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.
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Ocular Hypertension
Intervention: BETOPTIC S (betaxolol HCl) (Drug); Timolol Gel-forming Solution (timolol maleate) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Alcon Research
Summary
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Eligibility
Minimum age: N/A.
Maximum age: 5 Years.
Gender(s): Male.
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
Locations and Contacts
Alcon Call Center, Fort Worth, Texas, United States
Additional Information
Starting date: January 2003
Last updated: August 4, 2008
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