Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

Glaucoma Clinical Trial

Official title:

Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061516
• Other study ID #: C-00-17
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2003
• Last updated: November 16, 2016
• Start date: January 2003
• Est. completion date: February 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 both BETAXON and AZOPT 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: 78
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

INCLUSION:

• Children 5 years old and younger

• require treatment for glaucoma or ocular hypertension

• vision is 20/80 or better

• 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, carbonic anhydrase inhibitors or sulfa drugs

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:
• BETAXON (levobetaxolol HCl)
levobetaxolol suspension, 0.5%
• AZOPT (brinzolamide)
brinzolamide suspension, 1%

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

References & Publications (1)

Whitson JT, Roarty JD, Vijaya L, Robin AL, Gross RD, Landry TA, Dickerson JE, Scheib SA, Scott H, Hua SY, Woodside AM, Bergamini MV; Brinzolamide Pediatric Study Group.. Efficacy of brinzolamide and levobetaxolol in pediatric glaucomas: a randomized clini — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change from Baseline IOP		Up to Week 12