Abstract
BackgroundAn artificial-tear formulation containing the dual polymers hydroxypropyl guar (HPG) and hyaluronic acid (HA) is approved for the treatment of dry-eye disease (DED). The present study compared the efficacy and safety of the HPG-HA dual-polymer formulation vs a sodium hyaluronate (SH)-containing artificial-tear formulation in patients with DED.MethodsIn a prospective, 6-week, multicenter, double-masked, parallel-group study, patients with DED aged ≥18 years and total ocular surface staining (TOSS) score ≥4 and ≤9 were randomized (1:1) to receive either HPG-HA or SH four times a day for 42 days. Changes from baseline in TOSS (primary end point), impact of dry eye on everyday life (IDEEL) treatment-satisfaction scores (effectiveness and inconvenience), and tear-film breakup time (TFBUT) at day 42 were assessed using a fixed-sequence testing strategy. Noninferiority was assessed on the primary end point based on the upper limit of two-sided 95% CIs for mean treatment difference (HPG-HA or SH) <2 units.ResultsIn total, 99 patients were randomized (HPG-HA, n= 50; SH, n= 49). At day 42, the least square (LS) mean ± SE change from baseline in TOSS was −1.16±0.24 and −0.92±0.23 in the HPG-HA and SH groups, respectively, and the treatment difference was −0.24±0.33 (95% CI −0.90 to 0.42). Noninfe-riority was demonstrated as the upper limit of the 95% CI was <2 units. LS mean change from baseline at day 42 for HPG-HA vs SH was −3.18 (P=0.4817) in IDEEL treatment-effectiveness scores, −12.56 (P=0.0001) in treatment-inconvenience scores, and 0.30 seconds (P=0.5789) in TFBUT.ConclusionThe HPG-HA dual-polymer formulation was noninferior to the SH lubricant eye-drops for improvement in ocular surface staining in DED. HPG-HA did not show improvement over SH in IDEEL treatment-satisfaction scores. No new safety findings were reported.
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