Effect of Diquafosol On Worst Symptom of Dry Eye Patients: Focus on Photophobia

Abstract

Abstract: : Purpose: To compare the effects of 2% diquafosol and placebo on photophobia in dry eye patients that identified photophobia as their most bothersome symptom. Background: Historically, measuring the therapeutic effect on symptoms of dry eye disease subjects has been difficult. Patients report a variety of symptoms with the severity of each complaint varying from individual to individual. However, subjects generally describe a predominant ("worst") symptom. Commonly reported symptoms in dry eye patients include photophobia (P), burning, itching, and foreign body sensation. In a recently reported Phase 3 trial, approximately 28% of patients scored P as their most severe of the four symptoms during baseline. Methods: Results are presented for a post–hoc analysis of data from a Phase 3 clinical trial of diquafosol versus placebo in 527 dry eye patients. The subgroup of subjects with photophobia as the most bothersome symptom at baseline were analyzed with respect to improvement, and their characteristics described. Results: Compared to the overall population, subjects with P as their worst symptom at baseline were more likely to be non–Caucasian, had slightly higher corneal staining scores, more artificial tear use and lower tear break–up times. Percentage of subjects who had ≥50% reduction in P symptoms for the placebo and 2% diquafosol and placebo groups are shown in the following table. 

*p<0.05 compared to placebo In the subgroup of subjects whose worst symptom was P, those treated with diquafosol were 2–3 times more likely to experience a marked reduction in the severity of P. This result is consistent with the mechanism of action of the drug; improvement in tear film components, with increased stability of tear film.

Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • cornea: clinical science • pharmacology