Treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop: Prospective double-blind randomized study

• Prospective controlled double-blinded randomized study.
• We compare the clinical outcomes of SS dry eye patients treated with 0.03% tacrolimus eye drops.
• All patients in the study group showed improvement of dry eye symptoms.
• All patients in the tacrolimus group showed improvement of BUT, Schirmer I test, fluorescein and Rose Bengal scores after treatment.
• Larger series with longer duration of follow-up may provide more information.

ObjectiveTo describe the clinical efficacy of the treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop.DesignProspective double-blind randomized study.SettingInstitutional outpatient clinic.ParticipantsForty-eight eyes of twenty-four patients with dry eye related to Sjögren syndrome were enrolled in this study. The patients were randomized in 2 groups: tacrolimus (n = 14) and vehicle (n = 10) group.InterventionThe tacrolimus group received a vial containing tacrolimus 0.03% (almond oil as vehicle) and the other group received the almond oil vehicle. All patients were instructed to use the eye drops every 12 h in the lower conjunctival sac.Main outcome measuresSchirmer I test, break-up-time (BUT), corneal fluorescein and Rose Bengal staining scores were evaluated in all patients one day before the treatment (baseline), 7, 14, 28 and 90 days after treatment with the eye drops.ResultsThe average fluorescein and Rose Bengal scores improved statistically after 7 days of treatment and even more after 90 days. The average Schirmer I and BUT values were unchanged after 7, 14 and 21 days but did show an improvement relative to baseline after 28 days of treatment. Schirmer I, BUT, fluorescein and Rose Bengal did not show any statistical significance in the vehicle group.ConclusionTopical 0.03% tacrolimus eye drop improved tear stability and ocular surface status in cases of inflammatory or SS-related dry eye.Trial registrationClinicalTrials.gov Identifier: NCT01850979.