Comparison of Two Preservative-Free Artificial Tears with Sodium Hyaluronate for Relief of Dry Eye Symptoms: A Randomized, Investigator-Masked Study
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Purpose: To compare the performance of two preservative-free artificial tears with sodium hyaluronate (SH) in patients with moderate-to-severe dry eye: a 0.24% SH eye drop with carbomer (CB) and triglycerides (TGs) as lipids (SH-CB-TG), and a comparator with 0.18% SH (C-SH). Methods: Relief of Eye Surface by Triple Action (RESTA), a multicenter, investigator-masked, noninferiority study (NCT03368404) assessed patients with moderate-to-severe dry eye ( N = 79). Patients were randomized 1:1 to receive drops containing SH, CB, and medium-chain TGs [0.24% SH, 0.0625% CB, and 0.2% TGs; SH-CB-TG (Artelac® Complete); n = 45] versus an SH-only drop (0.18%; C-SH; n = 34) instilled 3–6 times daily for 90 days. The primary endpoint was change from baseline to Day 28 in total ocular surface fluorescein staining (OSFS) with noninferiority defined as a between-group 95% confidence interval (CI) upper bound <2 grades. Secondary endpoints included global OSFS at Day 90, individual OSFS component scores, dry eye symptoms, tear film break-up time, Schirmer’s test, quality of life (QoL) measures, and instillation frequency. Results: At Day 28, mean OSFS score in the SH-CB-TG group decreased by 2.07 ± 1.67 versus 1.50 ± 1.64 for C-SH; the 95% CI upper limit was 0.13, confirming noninferiority. Dry eye signs, symptoms, and QoL measures improved continuously in both groups, with the SH-CB-TG group showing significantly improved QoL globally at Day 90 ( P = 0.0306) and across several individual QoL parameters, plus an acceptable safety profile. Conclusions: Including medium-chain TGs in dry eye drops provides noninferior improvements of dry eye signs and symptoms versus viscosity agent-only drops and may enhance patient QoL.
Institutions: Inserm, Commissariat à l'Énergie Atomique et aux Énergies Alternatives, Université Paris-Saclay, Centre hospitalier national d'ophtalmologie des Quinze-Vingts, CEA Paris-Saclay - Etablissement de Fontenay-aux-roses, Assistance Publique – Hôpitaux de Paris, Infectious Disease Models and Innovative Therapies, Bicêtre Hospital, Universidad Complutense de Madrid, Hospital Clínico San Carlos, Clínica Rementería, Ankara University, Aristotle University of Thessaloniki, University Hospitals of the Ruhr-University of Bochum, Ruhr University Bochum
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4416807878