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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061542
• Other study ID #: C-01-01
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2003
• Last updated: November 16, 2016
• Start date: January 2003
• Est. completion date: November 2006

Study information

• Verified date: August 2008
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Hypertension
• Ocular Hypertension

Intervention

Drug:
• BETOPTIC S (betaxolol HCl)
betaxolol HC)
• Timolol Gel-forming Solution (TGFS)
timolol maleate 0.25% and 0.5%

Locations

Country	Name	City	State
United States	Alcon Call Center	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in IOP		Up to Week 12