William Trattler1, Robert J Noecker, Melissa L Earl. 1. Center for Excellence in Eye Care, Baptist Medical Arts Building, East Tower, 8940 North Kendall Drive, Suite 400-E, Miami, FL 33176, USA. wtrattler@gmail.com
Abstract
INTRODUCTION: The aim of this study was to evaluate the incidence of hyperaemia in patients using bimatoprost and to determine if simple interventions result in increased understanding of glaucoma and hyperaemia. METHODS: This was a multicentre, open-label, evaluator-masked clinical trial of 106 patients. Prior to enrolling in the trial, patients were washed out from any ocular hypotensive medications and prescribed bimatoprost daily in the evening for 6 weeks. Patients were randomised to one of two groups: intervention and no intervention. Patients in the intervention group (n=63) were given a fact sheet explaining the importance of reducing intraocular pressure (IOP) and the efficacy of bimatoprost, while patients in the no intervention group (n=43) were instructed only to instil bimatoprost daily and were given no additional instructions. RESULTS: As graded by the masked investigators, conjunctival hyperaemia peaked 1 day after commencing bimatoprost, with a mean of 1.2 (0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe). By day 7, hyperaemia levels were approximately trace (0.79) and continued to decrease throughout the study. There were no significant differences between groups in mean conjunctival hyperaemia at any study visit (P> or =0.215). At every visit, patients in the intervention group were significantly more likely than patients in the no intervention group to report that lowering IOP was very important for preserving vision (P< or =0.001). At week 6, 98% of patients in the intervention group reported that IOP-lowering was very important for preserving vision, compared with 76% of patients who did not receive the intervention (P< or =0.001). Patients in the intervention group were more likely than patients in the no intervention group to be willing to continue to use bimatoprost, despite hyperaemia. This difference was statistically significant at day 1 (P=0.003). CONCLUSION: Patients were not bothered by the trace.mild hyperaemia associated with bimatoprost therapy. Patient education can improve patient acceptance of a prescribed regimen and potentially increase compliance.
RCT Entities:
INTRODUCTION: The aim of this study was to evaluate the incidence of hyperaemia in patients using bimatoprost and to determine if simple interventions result in increased understanding of glaucoma and hyperaemia. METHODS: This was a multicentre, open-label, evaluator-masked clinical trial of 106 patients. Prior to enrolling in the trial, patients were washed out from any ocular hypotensive medications and prescribed bimatoprost daily in the evening for 6 weeks. Patients were randomised to one of two groups: intervention and no intervention. Patients in the intervention group (n=63) were given a fact sheet explaining the importance of reducing intraocular pressure (IOP) and the efficacy of bimatoprost, while patients in the no intervention group (n=43) were instructed only to instil bimatoprost daily and were given no additional instructions. RESULTS: As graded by the masked investigators, conjunctival hyperaemia peaked 1 day after commencing bimatoprost, with a mean of 1.2 (0=none, 0.5=trace, 1=mild, 2=moderate, 3=severe). By day 7, hyperaemia levels were approximately trace (0.79) and continued to decrease throughout the study. There were no significant differences between groups in mean conjunctival hyperaemia at any study visit (P> or =0.215). At every visit, patients in the intervention group were significantly more likely than patients in the no intervention group to report that lowering IOP was very important for preserving vision (P< or =0.001). At week 6, 98% of patients in the intervention group reported that IOP-lowering was very important for preserving vision, compared with 76% of patients who did not receive the intervention (P< or =0.001). Patients in the intervention group were more likely than patients in the no intervention group to be willing to continue to use bimatoprost, despite hyperaemia. This difference was statistically significant at day 1 (P=0.003). CONCLUSION:Patients were not bothered by the trace.mild hyperaemia associated with bimatoprost therapy. Patient education can improve patient acceptance of a prescribed regimen and potentially increase compliance.