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[Clinical evaluation of betaxolol in ophthalmic suspension with or without preservative agent in patients with glaucoma or ocular hypertension].

A prospective, randomized, cross-over, double-blind trial was designed to compare the safety and intraocular pressure (IOP) lowering effect of betaxolol 0.25% ophthalmic suspension with and without preservative (benzalkonium chloride). Twenty-seven patients with primary open angle glaucoma or with ocular hypertension were assigned randomly to receive either the preserved or the unpreserved unit dose betaxolol suspension first, followed by the second medication after a 7-10 day washout period. Both test medications significantly reduced IOP from baseline (p < 0.01) twelve hours after dosing at each observation times. IOP was reduced from a mean of 26.1 mmHg at baseline to 21.6 mmHg (preserved formulation) and from a mean of 25.7 mmHg at baseline to 22.3 mmHg (unpreserved formulation) on day 7. There were no significant differences between treatments, nor was there any evidence of any order effect. Adverse events possibly associated with study drugs included transient headache following instillation in one patient on both preserved and unpreserved formulations. It is concluded from this study that inclusion of a preservative in the betaxolol suspension formulation has no effect on the IOP control afforded by betaxolol, and that both preserved and unpreserved suspensions were safe for use in treatment of glaucoma and ocular hypertension.