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.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00061542
First received: May 28, 2003
Last updated: August 4, 2008
Last verified: August 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Alcon Research:
Glaucoma
Ocular Hypertension

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Glaucoma
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Timolol
Betaxolol
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-1 Receptor Antagonists

ClinicalTrials.gov processed this record on September 22, 2014