Assessment of the efficacy of Cationorm® in patients with moderate dry eye compared with Optive® and Emustil® eye drops

Abstract Purpose Dry eye disease (DED), the result of an insufficient tear film, is manifest by symptoms of ocular discomfort and ocular surface damage. An ideal DED therapy would regenerate each deficient tear film layer. Cationorm®, a preservative‐free cationic emulsion, augments the aqueous‐mucous and lipid layers of the tear film and reduces evaporation. The efficacy of Cationorm® was evaluated. Methods Adults with moderate DED defined by at least 1 symptom >3 cm on a visual analog scale (VAS) and total corneal fluorescein score ≥3 and tear film break up time (BUT) <7 seconds were enrolled in a 3 month, controlled, randomized, single‐masked study. Randomization to qid treatment with Cationorm® (Novagali), Optive® (Allergan) or Emustil® (SIFI) followed a washout period. Efficacy assessments were evaluated at 1 and 3 months. Results Of 71 patients, 8 (44%) Emustil treated patients discontinued prior to month 3. At month 1, the VAS score in Optive® and Cationorm® patients revealed a statistically significant improvement evident by month 3 for all treatments. Improvements in BUT and reduced fluorescein staining at month 3 were statistically significant for Cationorm® and Optive® but not Emustil®. While Cationorm® and Optive® significantly reduced tear film osmolarity only Cationorm® showed a statistically significant difference compared to Emustil®. Conclusion In moderate DED patients, Cationorm® was more effective than Emustil®. Although not statistically different, overall improvements were greater in patients treated with Cationorm® than Optive®.