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.

This study has been completed.

First Received: May 28, 2003 Last Updated: August 4, 2008 History of Changes

Sponsor:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00061542

Purpose

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.

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: BETOPTIC S (betaxolol HCl) Drug: Timolol Gel-forming Solution (timolol maleate)	Phase III

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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Timolol Timolol maleate Betaxolol Betaxolol hydrochloride

U.S. FDA Resources

Further study details as provided by Alcon Research:

Study Start Date:	January 2003
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 5 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061542

Locations

United States, Texas
Alcon Call Center
Fort Worth, Texas, United States

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

Study ID Numbers:	C-01-01
Study First Received:	May 28, 2003
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00061542 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

Glaucoma
Ocular Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Sympatholytics
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Betaxolol
Eye Diseases
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Glaucoma
Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Cardiovascular Diseases
Anti-Arrhythmia Agents
Timolol
Peripheral Nervous System Agents
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on November 27, 2009