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

Alcon Research105 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

105

Conditions

Glaucoma Ocular Hypertension

Interventions

BETOPTIC S (betaxolol HCl)DRUG

betaxolol HC)

Timolol Gel-forming Solution (TGFS)DRUG

timolol maleate 0.25% and 0.5%

Eligibility

Sex: MALEMin age: 1 WeekMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (1)

Alcon Call Center

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Mean change from baseline in IOP

Time frame: Up to Week 12

Data from ClinicalTrials.gov

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