Abstract
Purpose: :
To evaluate the Ocular Surface Disease Index (OSDI) subscale responses of subjects with dry eye disease using RemuraTM (bromfenac ophthalmic solution) over a six week period.
Methods: :
This is a retrospective analysis of 38 subjects diagnosed with dry eye disease who were dosed with Remura BID for 42 days in an open label, Phase 2, clinical trial. The OSDI responses were re-analyzed at the level of the subscales for symptoms, visual function, and environmental triggers. Scores for each subscale were produced as means of the summed sub scale question scores and plotted versus visit day. Changes in subscale score compared to baseline were performed and analyzed using a paired t-test. The subject-reported worst factor in each subscale was defined and the change from baseline calculated.
Results: :
Subjects dosing with Remura showed a reduction in each of the subscales; the change from baseline at each study visit for each of the subscales was statistically significant. The change from baseline in subscale score was significant as early as 14 days versus baseline. The worst factors reported for each subscale are those commonly associated with moderate dry eye.
Conclusions: :
Remura treats the common symptoms associated with mild-moderate dry eye disease with efficacy evident within 14 days of treatment.
Clinical Trial: :
http://www.clinicaltrials.gov NCT00758784
Keywords: cornea: tears/tear film/dry eye • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • clinical (human) or epidemiologic studies: outcomes/complications