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.
RCT Entities:
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 brinzolamidepatients 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. Levobetaxololpatients had mean change from baseline, ranging from -1.8 mm Hg (week 6) to -2.9 mm Hg (week 2). Levobetaxololpatients 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.