Study design
KCS
KCS, KERATOCONJUNCTIVITIS SICCA
Patients with at least 6 months’ history of keratoconjunctivitis sicca (KCS), who had not used cyclosporine in any form in the previous 90 days, and complained of an inadequate response to ongoing treatment were screened for eligibility to participate in the study. Eligible patients were asked to discontinue all previous treatment for DED other than tear substitutes, and were randomly assigned to one of three treatment arms in 1:1:1 ratio on the basis of a randomization schedule maintained at a central location off-site. The treatment arms were as follows:Treatment Arm A – MNP Cyclosporine 0.05% twice daily for the entire duration of the trial.Treatment Arm B – MNP Cyclosporine 0.05% twice daily for the first 4 weeks, and once daily for the remaining duration of the trial.Treatment Arm C – Restasis™ 0.05% twice daily for the entire duration of the trial.Patients were instructed to instil a single drop of the drug at each administration – once in the morning on waking and again at bedtime. Patients in Arm B were advised to administer the drug only at bedtime during the last 20 weeks of treatment. The use of tear substitutes was permitted and patients were provided with packs of Refresh Tears™ to be instilled into the eyes as required, but no more than 8 times a day, separated from study drug administration by at least 30 min. Study participants were asked to keep a calendar record of drug administration, symptoms of ocular side effects following drug administration, and the use of tear substitutes. Follow-up visits were scheduled 4, 8, 12 and 24 weeks after the start of treatment.