TY - JOUR
T1 - Efficacy of brinzolamide and levobetaxolol in pediatric glaucomas
T2 - A randomized clinical trial
AU - Whitson, Jess T.
AU - Roarty, John D.
AU - Vijaya, Lingam
AU - Robin, Alan L.
AU - Gross, Robert D.
AU - Landry, Theresa A.
AU - Dickerson, Jaime E.
AU - Scheib, Sally A.
AU - Scott, Haydn
AU - Hua, Steven Y.
AU - Woodside, Adrienne M.
AU - Bergamini, Michael V W
N1 - Funding Information:
This research was supported by Alcon Research, Ltd., Fort Worth, TX, and by an unrestricted grant from Research to Prevent Blindness to JTW.
PY - 2008/6
Y1 - 2008/6
N2 - Purpose: To describe the safety and clinical response on elevated intraocular pressure (IOP) of brinzolamide and levobetaxolol in pediatric patients under 6 years of age. Methods: A double-masked, randomized design. Pediatric patients were randomized to brinzolamide suspension, 1%, or levobetaxolol suspension, 0.5%, both dosed twice daily. IOPs at 9 AM were taken at screening, baseline, and weeks 2, 6, and 12. A descriptive study with mean change from baseline IOP, the primary efficacy parameter. Results: Seventy-eight evaluable patients (32 brinzolamide and 46 levobetaxolol). Patients on no prestudy IOP-lowering therapy randomized to brinzolamide had mean IOP change from baseline ranging from -4.1 mm Hg (week 2) to -5.0 mm Hg (week 6). When all brinzolamide patients are considered, there was little mean change from baseline IOP due to the large number of patients enrolled without a washout of prior IOP-lowering therapy. Levobetaxolol patients had mean change from baseline, ranging from -1.8 mm Hg (week 6) to -2.9 mm Hg (week 2). Levobetaxolol patients on no prestudy therapy had mean IOP change from baseline ranging from -2.9 mm Hg (week 12) to -4.0 mm Hg (week 2). Brinzolamide was more efficacious for glaucoma associated with systemic or ocular abnormalities and less efficacious for primary congenital glaucoma. Levobetaxolol was most efficacious for primary congenital glaucoma. Adverse events were predominantly nonserious and did not interrupt patient continuation in the study. Conclusions: Both brinzolamide and levobetaxolol were well tolerated. Both drugs provided clinically relevant IOP reductions for patients not on a previous medication, although efficacy is, in part, contingent upon diagnosis.{A figure is presented}.
AB - Purpose: To describe the safety and clinical response on elevated intraocular pressure (IOP) of brinzolamide and levobetaxolol in pediatric patients under 6 years of age. Methods: A double-masked, randomized design. Pediatric patients were randomized to brinzolamide suspension, 1%, or levobetaxolol suspension, 0.5%, both dosed twice daily. IOPs at 9 AM were taken at screening, baseline, and weeks 2, 6, and 12. A descriptive study with mean change from baseline IOP, the primary efficacy parameter. Results: Seventy-eight evaluable patients (32 brinzolamide and 46 levobetaxolol). Patients on no prestudy IOP-lowering therapy randomized to brinzolamide had mean IOP change from baseline ranging from -4.1 mm Hg (week 2) to -5.0 mm Hg (week 6). When all brinzolamide patients are considered, there was little mean change from baseline IOP due to the large number of patients enrolled without a washout of prior IOP-lowering therapy. Levobetaxolol patients had mean change from baseline, ranging from -1.8 mm Hg (week 6) to -2.9 mm Hg (week 2). Levobetaxolol patients on no prestudy therapy had mean IOP change from baseline ranging from -2.9 mm Hg (week 12) to -4.0 mm Hg (week 2). Brinzolamide was more efficacious for glaucoma associated with systemic or ocular abnormalities and less efficacious for primary congenital glaucoma. Levobetaxolol was most efficacious for primary congenital glaucoma. Adverse events were predominantly nonserious and did not interrupt patient continuation in the study. Conclusions: Both brinzolamide and levobetaxolol were well tolerated. Both drugs provided clinically relevant IOP reductions for patients not on a previous medication, although efficacy is, in part, contingent upon diagnosis.{A figure is presented}.
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U2 - 10.1016/j.jaapos.2007.11.004
DO - 10.1016/j.jaapos.2007.11.004
M3 - Article
C2 - 18289898
AN - SCOPUS:45549094626
SN - 1091-8531
VL - 12
SP - 239.e1-239.e11
JO - Journal of AAPOS
JF - Journal of AAPOS
IS - 3
ER -