A multicentre randomised trial comparing the efficacy and safety of Remogen® Omega versus Cationorm® in the treatment of patients suffering from dry eye

Purpose Remogen® Omega is the first omega‐3 containing drop indicated in the treatment of dry eye syndrome (DES). It contributes to the maintenance of the physicochemical balance of the tear film and facilitates eye recovery. The aim of this study was to compare the efficacy and safety of Remogen® Omega and Cationorm® in patients with moderate to severe DES. Methods This was a randomised controlled, masked‐observer multicentre trial. Patients used 4 drops of Remogen® Omega or Cationorm® per day for 3 months. The primary efficacy endpoint was the change from baseline at D28 in the score of ocular surface staining with fluorescein (OSSF) using Oxford scale. Other efficacy parameters included the score of ocular surface staining with lissamine green, Schirmer I test, tear film break‐up time, ocular surface disease index score, symptoms intensity and frequency, treatment comfort and overall efficacy at D28 and D84. Safety was evaluated based on intraocular pressure, best‐corrected visual acuity, general external examination, slit lamp examination and occurrence of adverse events. Results In total, analysed intent‐to‐treat population consisted on 23 patients who were randomly assigned to Remogen® Omega (n = 10) or Cationorm® (n = 13) arms. Patients were in average 67.1 years old and 91.3% were women. Demographics were balanced between the two arms. Mean (standard deviation) reductions of ‐1.0 (1.1) and ‐0.7 (1.7) were observed for OSSF scores in Remogen® Omega (p = 0.01) and Cationorm® (p = 0.05) arms at D28 versus baseline, respectively. Similarly, improvements were observed in both treatment groups for other efficacy criteria. The only between‐arm difference detected was the duration of blur vision which was longer after administration of Remogen® Omega compared with Cationorm® at D28 and D84 (p < 0.01). Both treatments were considered as comfortable and satisfying by patients and investigators. No statistically significant between‐arm differences were observed for safety parameters and no safety issues were raised. Conclusions Observed results suggest that both treatments have a beneficial effect on DES symptoms alleviation.