Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)
Status:
Completed
Trial end date:
2014-01-10
Target enrollment:
Participant gender:
Summary
This study is being conducted to investigate the safety, comfort, and tolerability of 3
treatments: loteprednol etabonate ophthalmic (Lotemax®) gel 0.5 percent (%) administered
twice daily (BID) with or without cyclosporine ophthalmic emulsion (Restasis) 0.05%
administered BID, and Restasis 0.05% treatment alone for 12 weeks and at a follow-up safety
visit 1 week post-treatment. This study will also investigate the relative efficacy of
Lotemax gel 0.5% administered BID with or without Restasis 0.05% treatment administered BID
and of Restasis 0.05% treatment alone for the reduction of clinical signs or symptoms of
keratoconjunctivitis sicca (DED) over the first 4 weeks of a 12-week treatment period and at
the end of a 12-week treatment period.