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

May 28, 2003
August 4, 2008
January 2003
November 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00061542 on ClinicalTrials.gov Archive Site
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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.
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
  • Drug: BETOPTIC S (betaxolol HCl)
  • Drug: Timolol Gel-forming Solution (timolol maleate)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Male
up to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00061542
C-01-01
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Alcon Research
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Alcon Research
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP