Patient- and Physician-Reported Satisfaction Following Treatment With Bimatoprost 0.01% or Vehicle in Patients With Glaucoma or Ocular Hypertension (OHT)

Abstract

 

Purpose:

 

The efficacy of and safety of bimatoprost 0.01% has been reported in a phase 2 study of patients with glaucoma or OHT whose intraocular pressure (IOP) was adequately controlled with latanoprost. The purpose of this analysis was to evaluate patient- and physician-reported outcomes with treatment in that study.

 

Methods:

 

In this double-masked, multicenter, parallel-group study, 222 patients were enrolled. The mITT population consisting of randomized and treated patients who had the primary safety variable, macroscopic hyperemia, evaluated at baseline and Month 1 visits included 147 and 71 patients randomized (2:1) to once-daily bimatoprost 0.01% or vehicle, respectively. Patients assessed acceptability of treatment by a series of 6 questions: 2 relating to willingness to continue treatment and 4 relating to eye appearance. Physicians answered 2 questions regarding willingness to continue use of study medication. Wilcoxon rank-sum test was used to compare groups.

 

Results:

 

After 1 month of treatment, a statistically significant difference was observed in patients’ or physicians’ response of receiving or prescribing the randomized treatment in 4 categories (P<.001, see Table below) Change in eye appearance was reported by 7 (5%) patients in the bimatoprost arm and by 4 (6%) patients in the vehicle arm.

 

Conclusions:

 

Patient and physician acceptability of treatment significantly favored bimatoprost over vehicle.  

 

Clinical Trial:

 

www.clinicaltrials.gov NCT00538304

 

Keywords: clinical (human) or epidemiologic studies: outcomes/complications