Efficacy of a novel hydrogel formulation in human volunteers

Abstract

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.