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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

NCT ID: NCT00061542

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

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2006-11-30

Brief Summary

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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.

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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Betaxolol

Two doses daily for 12 weeks

Group Type EXPERIMENTAL

BETOPTIC S (betaxolol HCl)

Intervention Type DRUG

betaxolol HC)

TGFS 0.25%

Two doses daily for 12 weeks

Group Type EXPERIMENTAL

Timolol Gel-forming Solution (TGFS)

Intervention Type DRUG

timolol maleate 0.25% and 0.5%

TGFS 0.5%

Two doses daily for 12 weeks

Group Type EXPERIMENTAL

Timolol Gel-forming Solution (TGFS)

Intervention Type DRUG

timolol maleate 0.25% and 0.5%

Interventions

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BETOPTIC S (betaxolol HCl)

betaxolol HC)

Intervention Type DRUG

Timolol Gel-forming Solution (TGFS)

timolol maleate 0.25% and 0.5%

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

1 Week

Maximum Eligible Age

5 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alcon Call Center

Fort Worth, Texas, United States

Site Status

Countries

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United States

References

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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 0.25% and 0.5% in pediatric glaucoma: a randomized clinical trial. J AAPOS. 2009 Aug;13(4):384-90. doi: 10.1016/j.jaapos.2009.04.017.

Reference Type RESULT
PMID: 19683191 (View on PubMed)

Other Identifiers

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C-01-01

Identifier Type: -

Identifier Source: org_study_id