March 02, 2015
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Fluorometholone treatment faster than cyclosporine A for Sjögren’s syndrome ocular dryness

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Successful treatment of ocular dryness with fluorometholone occurred faster than treatment with cyclosporine A in patients with Sjögren’s syndrome, according to a recent report.

Between January 2013 and September 2013, researchers selected 40 patients with primary or secondary Sjögren’s syndrome (SS) from the Eye, Ear, Nose and Throat Hospital of Fudan University in Shanghai, China, for inclusion in a randomized, open, parallel-group study. Patients included in the study had non-anesthetized Schirmer test results of 5 mm per minute or less, a 1% corneal fluorescein staining (CFS) score of three or greater out of 12 and the presence of at least one serum antibody related to SS (anti-nuclear antibodies, rheumatoid factor, anti-SS-A/Ro or anti-SS-B/La).

Subjective symptoms were assessed using the Ocular Surface Disease Index (OSDI) at each examination. Impression cytology was performed using eye specimens from all patients at baseline and at each follow-up visit along with additional Schirmer tests.

The clinical trial design required patients to abstain from use of any eye drops and glucocorticoids for 2 weeks prior to enrollment, and patients with previous eye injury, eye infection, ophthalmological surgery in the prior 6 months or another uncontrolled illness were excluded. Women who were pregnant or lactating and postmenopausal women taking hormone therapy were also excluded.

Patients were randomly assigned to treatment with 0.1% fluorometholone (FML) and 0.1% hyaluronate four times per day or cyclosporine A (CsA) twice daily. Patients were followed up at 14, 28 and 56 days after initial treatment.

Of the original 40 patients, 19 patients in the FML group and 16 patients in the CsA group completed follow-up. At week 2, the FML score was significantly lower than the scores seen in the CsA group. No significant difference was seen at 4 or 8 weeks, suggesting that benefits of treatment with FML manifest more quickly, according to the researchers.

OSDI scores dropped more rapidly in the FML group, but no significant differences were seen in the FML group at week 4 and 8. At week 8, OSDI scores were similar in both groups.

The researchers proposed a treatment course with FML initially to rapidly control inflammation followed by CsA use as a consolidation therapy. – by Shirley Pulawski

Disclosures: The researchers report no relevant financial disclosures.