Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma: A randomized clinical trial

Purpose: To describe the safety profile and clinical response on elevated intraocular pressure (IOP) of betaxolol hydrochloride ophthalmic suspension 0.25% (betaxolol) and timolol maleate ophthalmic gel-forming solution (TGFS) (0.25% and 0.5%), in subjects under 6 years of age. Methods: Subjects were randomized to betaxolol 0.25% (twice daily) or TGFS (daily) (0.25% or 0.5%) in this double-masked study. IOPs were obtained at the same time of day (9 AM) at 2 baseline visits and weeks 2, 6, and 12. Mean change from baseline in IOP was the primary efficacy parameter. Results: One hundred five subjects were randomized (34 to betaxolol, 35 to TGFS 0.25%, 36 to TGFS 0.5%). Betaxolol, TGFS 0.25%, and TGFS 0.5% produced statistically significant mean reductions in IOP; mean reductions after 12 weeks of treatment were 2.3, 2.9, and 3.7 mm Hg, respectively. In subjects who were not being treated with topical IOP-lowering medication at baseline, mean IOP reductions after 12 weeks of treatment were 3.1, 4.8, and 3.8 mm Hg, respectively. In patients discontinuing 1 or more topical IOP-lowering medications at baseline, mean IOP reductions at Week 12 were 1.8, 1.8, and 3.7 mm Hg, respectively. Responder rates (≥15% reduction from baseline) for betaxolol, TGFS 0.25%, and TGFS 0.5% were 38.2, 45.7, and 47.2%, respectively. Adverse events were predominantly nonserious and did not interrupt patient continuation in the study. Conclusions: Betaxolol ophthalmic suspension 0.25%, TGFS 0.25%, and TGFS 0.5% were well tolerated. Despite low responder rates, all 3 treatments produced statistically significant mean reductions in IOP in pediatric glaucoma subjects.{A figure is presented}.