NCT00061516

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2003

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

November 18, 2016

Status Verified

August 1, 2008

Enrollment Period

3.1 years

First QC Date

May 28, 2003

Last Update Submit

November 16, 2016

Conditions

GlaucomaOcular Hypertension

Keywords

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean Change from Baseline IOP

    Up to Week 12

Study Arms (2)

Brinzolamide suspension, 1%

EXPERIMENTAL

Dosed twice daily for 12 weeks

Drug: AZOPT (brinzolamide)

Levobetaxolol suspension, 0.5%

EXPERIMENTAL

Dosed twice daily for 12 weeks

Drug: BETAXON (levobetaxolol HCl)

Interventions

BETAXON (levobetaxolol HCl)DRUG

levobetaxolol suspension, 0.5%

Levobetaxolol suspension, 0.5%
AZOPT (brinzolamide)DRUG

brinzolamide suspension, 1%

Brinzolamide suspension, 1%

Eligibility Criteria

Age1 Week - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 clinical trial. J AAPOS. 2008 Jun;12(3):239-246.e3. doi: 10.1016/j.jaapos.2007.11.004. Epub 2008 Mar 4.

    PMID: 18289898RESULT

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

brinzolamide

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2003

First Posted

May 30, 2003

Study Start

January 1, 2003

Primary Completion

February 1, 2006

Study Completion

February 1, 2006

Last Updated

November 18, 2016

Record last verified: 2008-08