Clinical Trial: Lotemax® Gel 0.5% and Restasis 0.05% in Subjects With Mild or Moderate Keratoconjunctivitis Sicca

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional




Official Title: A Randomized, Multi-Center, Parallel-Group, Safety and Efficacy Study of Lotemax® Gel 0.5% and Restasis 0.05% for 12 Weeks in Subjects With Mild or Moderate Keratoconjunctiv

Brief Summary: This study is being conducted to investigate the safety, comfort, and tolerability of 3 treatments: Lotemax® gel 0.5% administered twice daily (BID)with or without 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.