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

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

Sponsoren

Hauptsponsor: Alcon Research

Quelle Alcon Research
Kurze Zusammenfassung

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.

Gesamtstatus Completed
Anfangsdatum January 2003
Fertigstellungstermin November 2006
Primäres Abschlussdatum November 2006
Phase Phase 3
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Mean change from baseline in IOP Up to Week 12
Einschreibung 105
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: BETOPTIC S (betaxolol HCl)

Beschreibung: betaxolol HC)

Armgruppenetikett: Betaxolol

Interventionsart: Drug

Interventionsname: Timolol Gel-forming Solution (TGFS)

Beschreibung: timolol maleate 0.25% and 0.5%

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: Male

Mindestalter: N/A

Maximales Alter: 5 Years

Gesunde Freiwillige: No

Ort
Einrichtung: Alcon Call Center
Standort Länder

United States

Überprüfungsdatum

August 2008

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Bedingung Durchsuchen
Anzahl der Waffen 3
Armgruppe

Etikette: Betaxolol

Art: Experimental

Beschreibung: Two doses daily for 12 weeks

Etikette: TGFS 0.25%

Art: Experimental

Beschreibung: Two doses daily for 12 weeks

Etikette: TGFS 0.5%

Art: Experimental

Beschreibung: Two doses daily for 12 weeks

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Double

Quelle: ClinicalTrials.gov