Efficacy in Patients with Dry Eye After Treatment with a New Lubricant Eye Drop Formulation

Purpose: The effective management of dry eye must include a clinically meaningful reduction in ocular staining. Evaluations of corneal and conjunctival staining and other ocular symptoms of dry eye were conducted for a new formulation of polyethylene glycol 400/propylene glycol-based lubricant eye drops containing hydroxypropyl guar as a gelling agent (Test Product) in comparison to Optive (TM) Lubricant Eye Drops (Control Product) in adult patients with dry eye. Methods: One hundred thirteen patients, 18 years of age and older, with dry eye were enrolled in a prospective, double-masked, multisite, parallel-group study. After a 2-week run-in period during which patients administered aqueous saline eye drops 4 times daily (QID) in each eye, patients were randomized (1: 1) to receive either Test Product or Control Product to be administered QID for 6 weeks. Efficacy and safety were evaluated by corneal and conjunctival staining scores, tear film breakup time, assessments of ocular symptoms, ocular surface disease index (OSDI) scores, dry eye treatment satisfaction, visual function-14 questionnaires, and adverse events. Results: The intent-to-treat data set included 105 patients randomized to Test Product (n=52) or Control Product (n=53). Patients primarily were between the ages of 18-64 years (70.5%), female (73.3%), white (93.3%), and not Hispanic (81.9%). Patients in the Test Product group exhibited significantly lower mean corneal staining scores than the Control Product group at day 14 (P=0.0009) and day 42 (P=0.0106), and significantly lower mean conjunctival staining scores at day 28 (P=0.0475) and day 42 (P=0.0009). Patients in both treatment groups reported significant reductions in the mean scores for the ocular symptoms of dryness, gritty/sandy feeling, and burning (P <= 0.0021 for all comparisons to baseline). Lastly, a significantly lower OSDI score than baseline was reported at day 42 by patients in both the Test Product (P=0.0013) and Control Product (P<0.0001) groups. Conclusions: The results of this study indicate that the Test Product significantly reduced corneal and conjunctival staining, indicating a reduction in disease severity. Evaluations of ocular staining scores provide clinically meaningful evidence of dry eye severity and are an important indicator of dry eye disease progression.