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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Collaborator: Synteract, Inc.
• Treatments: Cyclosporine; Cyclosporins; Loteprednol Etabonate; Lubricant Eye Drops; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• Have been diagnosed with or treated for keratoconjunctivitis sicca (DED) within 6 months prior to screening visit (Day -14).

• Have a baseline intraocular pressure (IOP) measurement of greater than or equal to (≥) 5 millimeters of mercury (mmHg) and less than or equal to (≤) 22 mmHg in each eye, with or without anti-glaucoma therapy.

• Have mild to moderate DED in 1 eye or both eyes at screening visit (Day -14) and randomization visit (Day 0).

Exclusion Criteria:

• Have a known hypersensitivity to corticosteroids, cyclosporine, fluorescein, lissamine green, topical anesthetic, or any component of either of the study drugs.

• Have severe DED.

• Have corneal erosive disease or other conditions suggestive of extensive damage of the cornea.

• Have a history of elevated IOP, a history of glaucoma, or IOP greater than (>) 22 mmHg in either eye at the screening visit (Day -14).

• Have had penetrating intraocular surgery in the past 12 months or require penetrating intraocular surgery during the study.

• Have had eyelid surgery within the 6 months prior to Visit 1 (Day -14) or have DED secondary to surgery.

• Have visible evidence of anterior lid Demodex spp. infection or infestation.

• Have had corneal refractive surgery or corneal transplantation.

• Have congenitally absent lacrimal or meibomian glands or have any obstructive disease of the lacrimal glands, sarcoidosis, or any other lacrimal gland deficiency.

• Have a diagnosis of on-going ocular infection, active anterior blepharitis, moderate to severe pinguecula, Stevens-Johnson syndrome, ocular cicatricial pemphigoid, significant conjunctival scarring, ocular chemical burn, or ocular neurotrophic keratitis.

• Have any serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance.

• Have a history of ocular herpetic keratitis or have had active blepharitis in the 4 weeks prior to the first dose.

• Have had ocular surgery (including laser) within 6 months prior to the first Treatment Period, or plan or require ocular surgery during the study. Neodymiumdoped:yttrium aluminum garnet (Nd:YAG) laser posterior capsulotomy is allowed.