Safety and Efficacy of an Artificial Tear Containing 0.3% Hyaluronic Acid in the Management of Moderate-to-Severe Dry Eye Disease

Purpose: To evaluate the safety and efficacy of a new 0.3% hyaluronic acid artificial tear compared with 0.9% saline solution (0.9% NaCl) in moderateto- severe dry eye patients after 1 month's use. Methods: A total of 16 patients with moderate-to-severe dry eye were included in this crossover study. After a 1-week washout period, patients used the experimental (Visaid 0.3%) or control solution (0.9% NaCl), selected randomly, applying three to eight drops daily for a month. After another washout period, patients used the other solution in the same way. Percentage of change (DY) was calculated and analyzed for (1) safety variables: visual acuity, intraocular pressure, and ophthalmoscopy evaluation; (2) efficacy variable: Ocular Surface Disease Index (OSDI) questionnaire; and (3) secondary variables: biomicroscopy findings, fluorescein corneal staining, lissamine green conjunctival staining, tear breakup time (TBUT), contrast sensitivity, Schirmer test, and subject satisfaction. Results: There were no significant differences in the safety parameters for either solution. After using Visaid 0.3%, patients showed significant improvements in OSDI score (Delta Y: -9.66%+/- 10.90), tarsal hyperemia (Delta Y: -16.67% +/- 27.89), corneal staining extension (Delta Y: 234.90% +/- 42.41), TBUT (Delta Y: 13.98% +/- 26.19), and subjective satisfaction (Delta Y: 38.06% 647.06). When using 0.9% NaCl, Schirmer test results were significantly worse (DY: -11.47% +/- 19.27). A significant difference between the 2 solutions was found in TBUT (Delta Y: 13.98% +/- 26.19 vs. 10.15% +/- 42.34, respectively; P = 0.0214). Conclusion: Visaid 0.3% is a safe product with some benefits over 0.9% NaCl in reducing ocular symptoms and improving some ocular signs in patients with moderate-to-severe dry eye.