Reversibility of Dry Eye Deceleration After Topical Cyclosporine 0.05% Withdrawal

Purpose: To assess the reversibility of clinical benefits of cyclosporine 0.05% (Restasis^®; Allergan, Inc., Irvine, CA) therapy and the therapeutic gain after its delayed use by switching treatment modalities in patients with dry eyes who completed a 1-year course of therapy with artificial tears (Refresh Endura^®; Allergan, Inc., Irvine, CA) or cyclosporine 0.05%.

Methods: This was a single-center, prospective, investigator-masked, longitudinal extension trial. Patients who had been treated with cyclosporine 0.05% in the first year of study were randomized in a 2:1 ratio to either cyclosporine 0.05% (Cs–Cs; n=20) or artificial tears (Cs–At; n=8), and those who had been originally randomized to artificial tears were switched to cyclosporine 0.05% (At–Cs; n=20) in the second year of study. Patients received study drugs twice daily for 12 months. Disease severity was assessed according to the International Task Force consensus guideline at months 0 and 12. Signs and symptoms were evaluated at baseline (month 0) and months 4, 8, and 12.

Results: At baseline, most patients with Cs–Cs and Cs–At (>90%) had level 2 disease severity, whereas almost half of the patients with At–Cs had level 3 disease severity. At month 12, a significantly higher percentage of patients with Cs–Cs and At–Cs than patients with Cs–At had the same or lower disease severity (P<0.001); whereas half of patients with Cs–At, compared with patients with no Cs–Cs and At–Cs, had disease progression at month 12. Throughout the study, dry eye signs and symptoms continuously improved in patients with Cs–Cs and At–Cs, whereas they constantly worsened in patients with Cs–At. At month 12, patients with Cs–Cs and At–Cs had significantly greater mean percentage improvement from baseline than did patients with Cs–At in Schirmer test scores, tear breakup time, Oxford staining scores, Ocular Surface Disease Index scores, and conjunctival goblet cell density (P<0.001). Overall, sign and symptom scores of patients with At–Cs did not improve as much as they did for patients with Cs–Cs.

Conclusions: Cyclosporine 0.05% withdrawal led to disease progression, thus indicating the necessity for maintenance therapy. Earlier treatment with cyclosporine 0.05% may result in improved outcomes.