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

NCT ID: NCT00061516

Last Updated: 2016-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Keywords

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Brinzolamide suspension, 1%

Dosed twice daily for 12 weeks

Group Type EXPERIMENTAL

AZOPT (brinzolamide)

Intervention Type DRUG

brinzolamide suspension, 1%

Levobetaxolol suspension, 0.5%

Dosed twice daily for 12 weeks

Group Type EXPERIMENTAL

BETAXON (levobetaxolol HCl)

Intervention Type DRUG

levobetaxolol suspension, 0.5%

Interventions

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BETAXON (levobetaxolol HCl)

levobetaxolol suspension, 0.5%

Intervention Type DRUG

AZOPT (brinzolamide)

brinzolamide suspension, 1%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

1 Week

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 18289898 (View on PubMed)

Other Identifiers

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C-00-17

Identifier Type: -

Identifier Source: org_study_id