CompletedPhase 3

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

78 participantsStarted 2003-01

Plain-language 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.

Who can participate

Age range1 Week – 5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

INCLUSION: * 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

What they're measuring

Mean Change from Baseline IOP

Timeframe: Up to Week 12

Trial details

NCT IDNCT00061516

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-02

View on ClinicalTrials.gov More Glaucoma trials