Abstract
Abstract: :
Purpose: Dry eye is a heterogeneous disease that arises from multiple etiologies. Diquafosol tetrasodium (DQT) is a novel topical treatment under development for dry eye that acts by stimulating P2Y2 receptors on the ocular surface to release water, mucin, and lipids, which leads to significant reductions in corneal staining in a heterogeneous study population. Methods: Corneal staining scores were examined in subgroups of patients to determine if there were significant variations among subgroups in the response to DQT. Patients receiving 2% DQT (n=195) or placebo (n=222) in two studies were pooled for this analysis. Subgroups included age (<65; 65–74; ≥75 years), gender (male/female), race (Caucasian; non–Caucasian), Sjögren’s status (yes/no), concurrent allergies (yes/no), use of medications with drying properties or hormonal or immunomodulatory properties (yes/no), artificial tear use [≤4 times/day; >4 times/day and use prior to study (yes/no)], and dry eye disease severity (baseline corneal staining: ≤1.0; >1.0–2.0; >2.0 and baseline tear break–up time: <4 sec; ≥4 sec). Results: The response to treatment with DQT in corneal staining was consistently positive. No significant treatment by subgroup interactions were observed for any subgroup with the exception of dry eye severity, indicating consistent benefit across a broad range of subjects. Subjects with more severe dry eye disease had a significantly greater reduction in corneal staining than the complementary groups of subjects with less severe disease. Conclusion: DQT should provide benefit to a broad spectrum of patients with dry eye, regardless of the underlying etiology.
Keywords: cornea: tears/tear film/dry eye • cornea: surface mucins