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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.

For Condition: Ocular Hypertension,Glaucoma
Status: Recruiting
Sponsor(s): Alcon Research ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /5 Years
Genders: Male
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Alcon Call Center *Recruiting*
Ft. Worth,  Texas, 
United States
Recruiting   (888)451-3937 (EYES)


Additional Information:
Study ID Numbers:
  C-01-01; 
Study Start Date: January 2003
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061542

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