[Study on the treatment of dry eye with Loteprednol Etabonate].

Objective: To observe the efficacy and safety of 0.5% Loteprednol Etabonate ophthalmic suspension in the treatment of moderate dry eye.

Methods: Totally 34 dry eye patients (68 eyes) in grade 2 or grade 3 (DEWS standard) enrolled in our hospital from March 2009 to September 2010 were randomly divided into two groups: the experimental group (Loteprednol Etabonate Group) and the control group (Cyclosporine A, CsA group). 0.5% Loteprednol Etabonate ophthalmic suspension or 1% CsA eye drops was applied 2 times a day respectively together with 0.2% Liposic eye drops (4 - 6 times/day). Questionnaire was used in these patients before the treatment and repeated every 2 weeks during the treatment till 8 weeks. Slit lamp microscope examination, fluorescent staining, tear break-up time (BUT), Schirmer I test (SIt) and intraocular pressure measurement were carried out at the same time point. The conjunctival impression cytology (IC) was performed before the treatment and 8 weeks after the treatment. The mean of the results were compared by t-tests and χ(2) test.

Results: After 2 weeks of the treatment, the mean score of the questionnaire was significantly lower than that before the treatment in each group (t = 5.36, 3.63, P < 0.01). After 4 weeks of the treatment, the inflammation of the ocular surface was relieved obviously in both group and the mean score of the corneal fluorescein staining (FL) was lower than that before the treatment in each group. The average density of the goblet cells before the treatment was (181.2 ± 16.1)/mm(2) and (179.4 ± 17.5)/mm(2) in each group respectively. After 8 weeks of the treatment, this increased to (348.6 ± 22.5)/mm(2) and (360.4 ± 27.8)/mm(2) significantly (t = 16.9, 16.3, P < 0.05). BUT was significantly prolonged in each group after the treatment (P < 0.01). There was no significant change in ST I or NCT in each group (P > 0.05).

Conclusions: Topical 0.5% Loteprednol Etabonate ophthalmic suspension is safe and effective for the treatment of moderate dry eye.