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Betaxolol Hydrochloride Ophthalmic Suspension 0.25% and Timolol Gel-Forming Solution 0.25% and 0.5% in Pediatric Glaucoma: A Randomized Clinical Trial

David A Plager, Jess T Whitson, Peter A Netland, Lingam Vijaya, Parthasarathy Sathyan, Devindra Sood, S R Krishnadas, Alan L Robin, Robert D Gross, Sally A Scheib, Haydn Scott, Jaime E Dickerson, BETOPTIC S Pediatric Study Group

J AAPOS. 2009 Aug;13(4):384-90.

PMID: 19683191

Abstract:

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 (> or =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.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
AP63659198-A Betaxolol hydrochloride Betaxolol hydrochloride 63659-19-8 Price
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