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

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Abstract

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 moderate-to-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 (ΔY) 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 (ΔY: −9.66%±10.90), tarsal hyperemia (ΔY: −16.67%±27.89), corneal staining extension (ΔY: −34.90%±42.41), TBUT (ΔY: 13.98%±26.19), and subjective satisfaction (ΔY: 38.06%±47.06). When using 0.9% NaCl, Schirmer test results were significantly worse (ΔY: −11.47%±19.27). A significant difference between the 2 solutions was found in TBUT (ΔY: 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.

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