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

Research output: Contribution to journalArticle

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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 (≥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}.

Original languageEnglish (US)
Pages (from-to)384-390
Number of pages7
JournalJournal of AAPOS
Volume13
Issue number4
DOIs
StatePublished - Aug 2009

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Betaxolol
Timolol
Glaucoma
Suspensions
Randomized Controlled Trials
Gels
Pediatrics
Intraocular Pressure
Double-Blind Method

ASJC Scopus subject areas

  • Ophthalmology
  • Pediatrics, Perinatology, and Child Health

Cite this

Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma : A randomized clinical trial. / Plager, David A.; Whitson, Jess T.; Netland, Peter A.; Vijaya, Lingam; Sathyan, Parthasarathy; Sood, Devindra; Krishnadas, S. R.; Robin, Alan L.; Gross, Robert D.; Scheib, Sally A.; Scott, Haydn; Dickerson, Jaime E.

In: Journal of AAPOS, Vol. 13, No. 4, 08.2009, p. 384-390.

Research output: Contribution to journalArticle

Plager, DA, Whitson, JT, Netland, PA, Vijaya, L, Sathyan, P, Sood, D, Krishnadas, SR, Robin, AL, Gross, RD, Scheib, SA, Scott, H & Dickerson, JE 2009, 'Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma: A randomized clinical trial', Journal of AAPOS, vol. 13, no. 4, pp. 384-390. https://doi.org/10.1016/j.jaapos.2009.04.017
Plager, David A. ; Whitson, Jess T. ; Netland, Peter A. ; Vijaya, Lingam ; Sathyan, Parthasarathy ; Sood, Devindra ; Krishnadas, S. R. ; Robin, Alan L. ; Gross, Robert D. ; Scheib, Sally A. ; Scott, Haydn ; Dickerson, Jaime E. / Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma : A randomized clinical trial. In: Journal of AAPOS. 2009 ; Vol. 13, No. 4. pp. 384-390.
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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 (≥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}.",
author = "Plager, {David A.} and Whitson, {Jess T.} and Netland, {Peter A.} and Lingam Vijaya and Parthasarathy Sathyan and Devindra Sood and Krishnadas, {S. R.} and Robin, {Alan L.} and Gross, {Robert D.} and Scheib, {Sally A.} and Haydn Scott and Dickerson, {Jaime E.}",
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T1 - Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma

T2 - A randomized clinical trial

AU - Plager, David A.

AU - Whitson, Jess T.

AU - Netland, Peter A.

AU - Vijaya, Lingam

AU - Sathyan, Parthasarathy

AU - Sood, Devindra

AU - Krishnadas, S. R.

AU - Robin, Alan L.

AU - Gross, Robert D.

AU - Scheib, Sally A.

AU - Scott, Haydn

AU - Dickerson, Jaime E.

PY - 2009/8

Y1 - 2009/8

N2 - 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}.

AB - 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}.

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