Ocular hypotensive efficacy and safety of a combined formulation of betaxolol and pilocarpine

Purpose: To evaluate the ocular hypotensive efficacy and safety of a fixed combination on betaxolol (0.25%) and pilocarpine (1.75%). Methods: Three multicenter, double-masked, parallel trials we completed in patients with primary open-angle glaucoma or ocular hypertension of 3 months treatment duration. Studies 1 and 2 were three-arm comparisons of betaxolol, pilocarpine, and a fixed combination, each used 3 times daily. Study 3 was a two-arm study of the fixed combination with and without a surfactant, used twice daily. In all studies, there was a 1-month run-in period with betaxolol 0.25% suspension given twice daily. There were 182 patients in Study 1, 186 patients in Study 2, and 166 patients in Study 3. Results: In all 3 studies, approximately 10% to 15% of patients treated with pilocarpine or the combination therapy were terminated from further participation because of typical pilocarpine side effects (eg, blurred vision, headache). In studies 1 and 2, there was a mean reduction in intraocular pressure from a betaxolol baseline of approximately 3 to 4 mmHg. Patients continuing on betaxolol alone or randomly assigned to pilocarpine alone experienced a mean reduction of 1 to 2 mm Hg. Overall, the combination was approximately 2 mmHg more effective than either betaxolol or pilocarpine alone. In Study 3, the two betaxolol combinations had equivalent efficacy. Conclusions: In patients requiring more than one ocular hypotensive agent, the combination of betaxolol and pilocarpine in a single formulation appears to be an effective and relatively safe agent. The use of this combination agent promises the potential for enhanced patient convenience.