Betaxolol hydrochloride ophthalmic suspension 0.25% and timolol gel-forming solution 0.25% and 0.5% in pediatric glaucoma: a randomized clinical trial.
OBJECTIVE
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.
Plager
David A
DA
Indiana University School of Medicine, Indianapolis, IN, USA.
Whitson
Jess T
JT
Netland
Peter A
PA
Vijaya
Lingam
L
Sathyan
Parthasarathy
P
Sood
Devindra
D
Krishnadas
S R
SR
Robin
Alan L
AL
Gross
Robert D
RD
Scheib
Sally A
SA
Scott
Haydn
H
Dickerson
Jaime E
JE
D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015784:Betaxolol / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D005901:Glaucoma / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007429:Intraocular Pressure / Q000187:drug effects*; D008297:Male; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D013535:Suspensions; D013999:Timolol / Q000008:administration & dosage* / Q000009:adverse effects; D014065:Tonometry, Ocular; D014792:Visual Acuity
D000959:Antihypertensive Agents; D005782:Gels; D009883:Ophthalmic Solutions; D013535:Suspensions; D013999:Timolol; D015784:Betaxolol