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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00061542

Enrollment

105

Registered

2003-05-30

Start date

2003-01-31

Completion date

2006-11-30

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension

Keywords

Glaucoma, Ocular Hypertension

Brief 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.

Interventions

DRUGBETOPTIC S (betaxolol HCl)

betaxolol HC)

DRUGTimolol Gel-forming Solution (TGFS)

timolol maleate 0.25% and 0.5%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

1 Weeks to 5 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Mean change from baseline in IOP	Up to Week 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026