Performance profile of sodium hyaluronate in patients with lipid tear deficiency: randomised, double-blind, controlled, exploratory study.

Aim: To assess the short-term efficacy of hypotonic 0.18% sodium hyaluronate in patients with evaporative tear-sufficient dry eye due to lipid tear deficiency (LTD).
Methods: This was a randomised, double-blind, controlled, exploratory study. A total of 10 patients with dry eye due to LTD were treated as follows: one drop of hypotonic 0.18% sodium hyaluronate in one eye and one drop of isotonic 0.3% hydroxypropyl-methylcellulose (HPMC)/0.1% dextran in the other eye. Non-invasive tear film break-up time (NIBUT) evaluated by using a tear scope with grid pattern and subjective ocular symptoms of dry eye were assessed at 15, 30, 60 and 90 min after instillation.
Results: Both sodium hyaluronate and HPMC/dextran caused a significant (p<0.05) improvement in NIBUT and symptoms. Mean (SD) NIBUT in the sodium hyaluronate group was 3.2 (1.0), 6.4 (2.8), 5.5 (1.9), 5.3 (1.3) and 3.9 (1.7) s at 0, 15, 30, 60 and 90 min, respectively, compared with 3.6 (1.9), 5.5 (3.2), 5.0 (1.5), 4.4 (2.2) and 3.5 (1.2) s in the HPMC/dextran group. However, increase in NIBUT was significantly (p<0.05) greater and longer in the sodium hyaluronate group than in the HPMC/dextran group.
Conclusion: Treatment with sodium hyaluronate and HPMC/dextran eye drops is useful for treating patients with dry eye due to LTD. However, sodium hyaluronate caused a significantly (p<0.05) greater increase in NIBUT values than HPMC/dextran in such patients.