Treatment with preservative-free 0.3% hyaluronic acid eye drops may improve both objective signs and patient-reported symptoms in patients with moderate-to-severe dry eye disease, according to a prospective multicenter clinical investigation published in Clinical Ophthalmology. The treatment appeared to be well tolerated during 60 days of follow-up, with one nonserious treatment-related adverse event reported.
Researchers conducted a prospective, postmarket, multicenter clinical investigation at three university hospitals in Italy to evaluate preservative-free 0.3% hyaluronic acid (HA) ophthalmic solution in adults with moderate-to-severe dry eye disease. A total of 51 patients were enrolled, including 50 in the intent-to-treat population, and received the eye drops three times daily for 60 days. Approximately 92% had at least one systemic comorbidity, including hypertension, hypercholesterolemia, Sjögren disease, and other musculoskeletal and connective tissue disorders, and 71% were receiving concomitant systemic medications. The primary endpoint was the change in National Eye Institute (NEI) corneal and conjunctival fluorescein staining score at 30 days. Secondary endpoints included changes in NEI score at 60 days, tear-film breakup time (TFBUT), Schirmer test I, noninvasive breakup time (NIBUT), tear meniscus height, conjunctival hyperemia, meibography, patient-reported symptoms assessed with the Impact of Dry Eye on Everyday Life (IDEEL) questionnaire, and safety.
The primary endpoint was met. Mean NEI staining scores decreased from 8.38 at baseline to 4.04 at day 30 and continued to decline to 3.60 at day 60, suggesting sustained improvement in ocular surface integrity. Tear-film stability also improved, with mean TFBUT increasing from 3.65 seconds at baseline to 6.51 seconds at day 30 and 7.26 seconds at day 60. Consistent with improved tear production, Schirmer test I values increased from 5.70 mm at baseline to 8.74 mm at day 30 and 9.62 mm at day 60.
Patient-reported outcomes were found to be consistent with the objective findings. Mean IDEEL Symptom-Bother scores improved from 59 at baseline to 45 at day 30 and 41 at day 60, representing an approximately 18-point reduction in symptom burden that exceeded the established threshold for clinically meaningful improvement. Tear meniscus height and conjunctival hyperemia also appeared to improve by day 60, whereas NIBUT did not show a statistically significant change, and meibography findings remained largely stable during follow-up.
Safety outcomes were reported as favorable overall. One patient experienced treatment-related blurred vision, and no treatment discontinuations or dose reductions were required.
The researchers noted several limitations. The study lacked a control group and masking, included a relatively small cohort, did not perform subgroup analyses, and had a 60-day follow-up period, limiting assessment of causality, generalizability, and long-term efficacy and safety.
"These results suggest that 0.3% ophthalmic solution with HA may represent a valuable option for managing symptoms in patients with moderate-to-severe [dry eye disease], even in the presence of concomitant systemic therapies," wrote lead study author Rita Mencucci, MD, of the University of Florence, and colleagues. However, larger controlled studies with longer follow-up are needed to confirm these findings.
The authors reported no conflicts of interest.
Source: Clinical Ophthalmology
