Performance and safety of a new preservative‐free eye drops in contact lens wearers with dry eye

Aims/Purpose: One of the most common reason for contact lens discomfort and drop out is dry eye. The aim of this study was to assess the performance of new preservative‐free eye drops Thealoz®Total containing sodium hyaluronate (SH) 0.15%, trehalose 3%, NAAGA (N‐Acetyl‐Aspartyl‐Glutamic Acid) 2.45% (Laboratoires Théa, Clermont‐Ferrand, France), in patients with subjective appreciation of ocular surface problems due to contact lenses (CL)wear.

Methods: A prospective, single‐arm, multicenter, 5‐week study included three visits: Day 1 (D1), D15 and D36 in 34 patients wearing CL daily, applying Thealoz®Total 3 to 6 times daily. The Ocular Surface Disease Index (OSDI) and the Contact Lens Dry Eye Questionnaire‐8 (CLDEQ‐8) were used to evaluate symptoms and quantify discomfort. Standardized clinical tests were performed to assess dry eye.

Results: The results for 34 participants were analyzed (FAS). The mean (SD) of the CLDEQ‐8 total score was 22.6 (4.6) at baseline, 13.5 (5.2) at D15 and 10.0 (4.7) with a mean Change From Baseline (CFB) of ‐12.6 (5.0) at D36 (p < 0.001). The mean (SD) OSDI score was 36.85 (16.29) at baseline, 19.37 (14.41) at D15, 12.71 (10.34) at D36 with a mean CFB of ‐24.14 (12.57) at D36 (p < 0.001). The mean CFB in the ocular discomfort score was ‐22.1 ± 18.3 mm at D15 and ‐32.6 ± 19.0 mm at D36 (p < 0.001). The mean CFB in total symptom score was ‐4.4 ± 2.4 at D15 and ‐6.3 ± 3.2 at D36 (p < 0.001). Most patients experienced an improvement of each symptom at D15 (50.0% for itching and 82.4% for dryness) and D36 (67.6% for itching and tearing, and 91.2% for dryness). A soothing sensation upon instillation was judged “important” by 47.1% of patients at D15, and increased to 79.4% at D36. Only two Treatment‐Emergent Adverse Event (TEAE) were experienced by 1 patient, and were non‐serious and of mild intensity (photophobia and instillation site discomfort).

Conclusions: This new eye drops containing SH 0.15%, trehalose 3%, NAAGA 2.45% has been shown to be efficacious on dry eye symptoms and ocular discomfort in CL wearers as soon as 15 days, with sustainable improvement in 36 days. This makes the drops safe and efficient, not only for CL users but for variety of therapeutic and postsurgical applications with utilization of CL.