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.

Search results

Comparison of Two Preservative-Free Artificial Tears with Sodium Hyaluronate for Relief of Dry Eye Symptoms: A Randomized,Investigator-Masked Study