A New Eye Drop Containing Naaga (N-Acetyl-Aspartyl-Glutamic Acid), Hyaluronic Acid And Trehalose For Dry Eye Relief In Contact Lens Wearers

One of the most common reason for ocular surface problems is Dry Eye (DE) associated with contact lenses (CL). According to TFOS Contact Lens Discomfort workshop in 2013, the prevalence of the condition ranging from 28-50.4%. The aim of this study was to assess the performance of new preservative-free eye drops Thealoz®Total containing sodium hyaluronate 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 CL wear.

The study was performed at Department of Ophthalmology and Visual Sciences, Faculty of Medicine, Medical University of Varna, Bulgaria, following the ethics and compliance rules.

A prospective, single-arm, multicenter, 5-week study included three visits: Day 1 (D1), D15 and D36 in 34 enrolled patients wearing CL daily. Patients applied Thealoz®Total 3 to 6 times daily, at any time but only when patients are wearing their contact lenses, and kept a strict diary.

DE symptoms were assessed with the Ocular Surface Disease Index (OSDI),  as well as the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). Ocular surface staining according to Oxford 0-15 grading scheme and conjunctival hypereamia using MacMonnies photographic scale (0-5) were performed in each eye. Ocular tolerance was assessed by the investigator and the patient using a 4-point scale and Best Corrected Visual Acuity (BCVA) for safety reasons.

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) (n=34). 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). 53% of patients had a grade of conjunctival hyperaemia ≥2 at baseline in the worst eye, 29.4% at D15 and 2.9% at D36. At D36, 82.4% improved compared to baseline values (p<0.001). The mean CFB for total ocular surface staining grade in the worst eye was -2.5 (1.8) at D15 and -4.4 (2.2) at D36 (p<0.001). Tolerance assessment was considered by all patients as satisfactory (14.7%) or very satisfactory (85.3%) at D36.

This new preservative-free eye drops containing sodium hyaluronate 0.15%, trehalose 3%, NAAGA 2.45% indicated for patients with moderate to severe DE, confirmed its efficacy on the relief of DE signs and symptoms in CL wearers as soon as 15 days of use and after 36 days, with a very good self-declared tolerance.  This might be a solution for other DE disease related to post cataract surgery, corneal procedure and/or combination with therapeutic CL.