NCT01817582

Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)

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 Keratoconjunctivitis Sicca (Dry Eye Disease; DED)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DRUG	Lotemax	Lotemax gel will be administered as per the dose and schedule specified in the arms.
DRUG	Restasis	Restasis emulsion will be administered as per the dose and schedule specified in the arms.
DRUG	Soothe® Lubricant Eye Drops

Timeline

• Start date: 2013-05-17
• Primary completion: 2014-01-10
• Completion: 2014-01-10
• First posted: 2013-03-25
• Last updated: 2019-08-30
• Results posted: 2019-08-30

Locations

1 site across 1 country: United States