Clinical trial of sustained-release artificial tears in keratoconjunctivitis sicca and Sjögren's syndrome.

The effect of sustained-release artificial tear inserts on symptoms and signs of reduced tear production in keratoconjunctivitis sicca (KCS) was evaluated in an open clinical trial including 30 patients. A significant relief of sicca symptoms and a decrease in keratoconjunctival staining were seen in 10 patients fulfilling the study, whereas no significant effect on Schirmer test and tear break-up-time could be detected, neither in patients with pure KCS nor with KCS as a manifestation of Sjögren's syndrome. Twenty patients (67%) withdrew due to adverse effects, which were reported in total 80% of the patients. Absence of measurable tear secretion predicted treatment failure. Due to the frequent side effects, the artificial tear inserts cannot be recommended as a first line treatment in KCS patients.