24-Hour IOP Control With Bimatoprost and the Bimatoprost/Timolol Fixed Combination Administered in the Morning, or Evening in Exfoliative Glaucoma

Abstract

Purpose: : To compare 24-hour IOP control of morning and evening administered bimatoprost/timolol fixed combination (BTFC) and evening administered bimatoprost in exfoliative glaucoma (XFG).

Methods: : One eye of 60 XFG patients was included in this prospective, observer-masked, crossover comparison. Following wash-out all patients received bimatoprost monotherapy for 6 weeks. They were then randomized to morning, or evening administered BTFC for 3 months and then switched to the opposite therapy.

Results: : At baseline, mean 24-hour pressure was 29.0 mmHg. Bimatoprost reduced the mean IOP by 8.1 mmHg (27.8%, p<0.001). The evening administration of BTFC reduced 24-hour IOP to a statistically lower level than morning administration (10.2 mmHg (35.3%) vs. 9.8 mmHg (33.8%); p=0.005). Both dosing regimens reduced IOP significantly more than bimatoprost (p≤0.006, for all time points). A 24-hour IOP reduction ≥30% was seen in 43 patients (72%) with evening BTFC compared with 39 patients (65%) with morning BTFC (p=0.344) and only 24 patients (40%) with bimatoprost monotherapy (p<0.001 vs both BTFC regimens).

Conclusions: : Both BTFC dosing regimens significantly reduce 24-hour IOP in XFG compared with bimatoprost monotherapy. The evening dosing gives rise to statistically better 24-hour IOP control, but the difference may not be clinically meaningful.

Clinical Trial: : www.clinicaltrials.gov NCT00486486

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials