Efficacy of a novel hydrogel formulation in human volunteers.
In a two-period crossover study, 20 subjects without an ocular disease received single doses of either a novel timolol hydrogel (T-Gel 0.1%) or aqueous timolol 0.5% in one eye and placebo in the fellow eye. Diurnal variation curves of intraocular pressure of both eyes were obtained for a 24-hour period. Peak effects up to -30% of the baseline were observed. A statistically significant residual effect was still detectable 24 h after application. The timolol gel had the same efficacy in lowering intraocular pressure as the commercially available aqueous timolol solution with a five times higher strength. Equivalence of treatment effects was statistically proved.
Mayer
H
H
Kinik und Poliklinik fur Augenheilkunde, Medizinische Hochschule Hannover, Deutschland.
von der Ohe
N
N
D000287:Administration, Topical; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D002940:Circadian Rhythm; D018592:Cross-Over Studies; D004337:Drug Carriers; D005260:Female; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; D007429:Intraocular Pressure / Q000187:drug effects* / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011092:Polyethylene Glycols; D012016:Reference Values; D012449:Safety; D016037:Single-Blind Method; D013999:Timolol / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000319:Adrenergic beta-Antagonists; D004337:Drug Carriers; D009883:Ophthalmic Solutions; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; D011092:Polyethylene Glycols; D013999:Timolol