Abstract
Purpose::
The purpose of this study was to evaluate the incidence of hyperemia in patients using bimatoprost and to determine if simple interventions result in increased understanding of glaucoma and hyperemia.
Methods::
Multicenter, open-label, evaluator masked trial. Patients (n=64) were randomized to intervention (Group 1) or no intervention (Group 2). For Group 1, office staff were asked to review a fact sheet explaining the importance of IOP lowering and the efficacy of bimatoprost. Patients were given this sheet to take home. Group 2 was instructed only to instill bimatoprost daily and was given no additional instructions. Visits were at baseline, days 1 and 7, month 1, and week 6. At each study visit, patients completed a questionnaire about any hyperemia and how it affected their willingness to continue bimatoprost.
Results::
As graded by investigators, conjunctival hyperemia peaked 1 day after commencing bimatoprost, with a mean of 1.1 (0.5=trace, 1=mild, 2=moderate, 3=severe). By Day 7, hyperemia levels were approximately trace (0.69) and continued to decrease throughout the study. At each visit, patients in Group 2 were slightly more bothered by hyperemia than were patients in Group 1. At each visit, Group 1 was more likely than Group 2 to report that lowering IOP was very important to preserving vision (for example, at Day 7, 90% and 65%, respectively, P=.016). Group 1 was more likely than Group 2 to be willing to continue to use bimatoprost, despite hyperemia (97% vs. 88% at Day 1, P=.293).
Conclusions::
Overall, hyperemia peaked at day 1 (to mild levels) and quickly returned to baseline. Patients in Group 1 were more aware of the importance of IOP lowering and were more willing to tolerate hyperemia. Most patients were not bothered by hyperemia. Patient education can improve patient acceptance of a prescribed regimen and potentially increase compliance.
Clinical Trial::
www.clinicaltrials.gov NCT00348062
Keywords: clinical (human) or epidemiologic studies: biostatistics/epidemiology methodology • clinical (human) or epidemiologic studies: outcomes/complications • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials