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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.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00061542
First received: May 28, 2003
Last updated: November 16, 2016
Last verified: August 2008
May 28, 2003
November 16, 2016
January 2003
November 2006   (Final data collection date for primary outcome measure)
Mean change from baseline in IOP [ Time Frame: Up to Week 12 ]
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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
The purpose of this study is 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.
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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Glaucoma
  • Ocular Hypertension
  • Drug: BETOPTIC S (betaxolol HCl)
    betaxolol HC)
  • Drug: Timolol Gel-forming Solution (TGFS)
    timolol maleate 0.25% and 0.5%
  • Experimental: Betaxolol
    Two doses daily for 12 weeks
    Intervention: Drug: BETOPTIC S (betaxolol HCl)
  • Experimental: TGFS 0.25%
    Two doses daily for 12 weeks
    Intervention: Drug: Timolol Gel-forming Solution (TGFS)
  • Experimental: TGFS 0.5%
    Two doses daily for 12 weeks
    Intervention: Drug: Timolol Gel-forming Solution (TGFS)
Plager DA, Whitson JT, Netland PA, Vijaya L, Sathyan P, Sood D, Krishnadas SR, Robin AL, Gross RD, Scheib SA, Scott H, Dickerson JE; BETOPTIC S Pediatric Study Group. Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma: a randomized clinical trial. J AAPOS. 2009 Aug;13(4):384-90. doi: 10.1016/j.jaapos.2009.04.017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
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
Sexes Eligible for Study: Male
up to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00061542
C-01-01
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Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
August 2008

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