A multicenter evaluation of levobunolol (Vistagan) in Germany.
We evaluated the efficacy and safety of 0.5% levobunolol HC1 (Vistagan) in 2,041 glaucoma patients at 143 sites in the Federal Republic of Germany. This study was a 3-month, open-label, noncomparative trial of levobunolol administered twice daily. Eighty-five percent of the patients completed the study period with well-controlled intraocular pressure (IOP). Treatment was discontinued in the remaining 15%: 7% for adverse reactions, 1% for lack of drug efficacy, and 7% for reasons unrelated to the study treatment. Efficacy, ocular drug tolerance, and systemic safety were judged as good to very good in approximately 80% of the patients. This large, postapproval study confirms previous findings of several well-controlled clinical trials indicating that levobunolol is an effective drug for the treatment of elevated IOP and is safe and comfortable for most patients.
Novack
G D
GD
Department of Ophthalmology Clinical Research, Allergan Pharmaceuticals, Irvine, Calif.
Kelley
E P
EP
Lue
J C
JC
D004334:Drug Administration Schedule; D004341:Drug Evaluation; D004342:Drug Hypersensitivity / Q000209:etiology; D005860:Germany, West; D005901:Glaucoma / Q000188:drug therapy*; D006801:Humans; D002040:Levobunolol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015337:Multicenter Studies as Topic
D002040:Levobunolol