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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.

This study has been completed.

Sponsored by: 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

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

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.

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


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

Keywords provided by Alcon Research:
Glaucoma  
Ocular Hypertension  

Study placed in the following topic categories:
Betaxolol
Glaucoma
Eye Diseases
Vascular Diseases
Timolol
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:
Sympatholytics
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2008




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