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OpenTrials
Completed

NCT Number: NCT00061542

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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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

1 week–5 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Alcon Call Center

Fort Worth, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BETOPTIC S (betaxolol HCl)

Drug

betaxolol HC)

Timolol Gel-forming Solution (TGFS)

Drug

timolol maleate 0.25% and 0.5%

Primary outcomes

  1. Mean change from baseline in IOP

    Time frame: Up to Week 12

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
May 30, 2003
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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