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

History of Changes

Tracking Information
First Received Date ^ICMJE	May 28, 2003
Last Updated Date	August 4, 2008
Start Date ^ICMJE	January 2003
Primary Completion Date	November 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00061542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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.
Official Title ^ICMJE	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.
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Glaucoma Ocular Hypertension
Intervention ^ICMJE	Drug: BETOPTIC S (betaxolol HCl) Drug: Timolol Gel-forming Solution (timolol maleate)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	November 2006
Primary Completion Date	November 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	up to 5 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00061542
Other Study ID Numbers ^ICMJE	C-01-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	August 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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