Osmoprotectants, carboxymethylcellulose and hyaluronic acid multi-ingredient eye drop: a randomised controlled trial in moderate to severe dry eye

M Labetoulle, F Chiambaretta, A Shirlaw, R Leaback, C Baudouin, M Labetoulle, F Chiambaretta, A Shirlaw, R Leaback, C Baudouin

Abstract

PurposeTo assess the safety and efficacy of an eye drop combining osmoprotectants, carboxymethylcellulose and hyaluronic acid (O/CMC/HA) in reducing symptomatic, moderate to severe dry eye, compared with HA.MethodsIn this investigator-masked, randomised study, patients instilled 1-2 drops/eye of O/CMC/HA or HA (2-6 times/day) for 3 months. Primary endpoint: mean change in Global Ocular Staining Score (GOSS) from baseline at day 35. Noninferiority of O/CMC/HA was tested in the per-protocol population; if achieved, superiority was tested in the intent-to-treat population. Secondary efficacy endpoints: mean change from baseline in GOSS, Ocular Surface Disease Index (OSDI), Schirmer score, tear break-up time (TBUT), corneal/conjunctival staining, conjunctival hyperaemia, symptoms, and patient/investigator assessments.ResultsBaseline characteristics were comparable between groups (n=40 each). O/CMC/HA was noninferior (and not superior) to HA based on similar GOSS reductions from baseline at day 35 and month 3 in both groups (P=0.778, day 35, per-protocol population). Overall, O/CMC/HA and HA provided similar reductions in OSDI, Schirmer score, TBUT, corneal staining and hyperaemia from baseline at 35 days (P≥0.155). More patients reported less severe stinging/burning, sandiness/grittiness, and painful/sore eyes at month 3 with O/CMC/HA (P≤0.039), and more rated the dropper bottle easy to use (87.5%), compared with HA (46.2%; P=0.002). Other patient and investigator assessments were similar between groups. O/CMC/HA and HA were well tolerated.ConclusionsO/CMC/HA is noninferior to HA in improving objective signs of dry eye, with potential advantages for subjective symptoms and patient acceptance.

Conflict of interest statement

ML has served as a consultant for Allergan, Alcon, Bausch and Lomb, MSD, Santen/Novagali and Théa; AS and RL are employees of Allergan plc; CB has served as a consultant for Alcon, Allergan, Santen and Théa; and FC declares no conflict of interest. The funding body was involved in the design, data analysis and interpretation, revision of the manuscript for intellectual content, and decision to submit the manuscript for publication.

Figures

Figure 1
Figure 1
Change from baseline in OSDI (a) and corneal staining (b) in the intent-to-treat population. HA, hyaluronic acid; O/CMC/HA, osmoprotectants/carboxymethylcellulose/hyaluronic acid; OSDI, ocular surface disease index.
Figure 2
Figure 2
Patient assessment of dry eye symptoms (a) and treatment acceptability (b). HA, hyaluronic acid; ITT, intent-to-treat; O/CMC/HA, osmoprotectants/carboxymethylcellulose/hyaluronic acid.

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