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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

Page last updated: August 23, 2015

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