Status:
COMPLETED
Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)
Lead Sponsor:
Bausch & Lomb Incorporated
Collaborating Sponsors:
Synteract, Inc.
Conditions:
Keratoconjunctivitis Sicca
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2014
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT01817582
Start Date
May 17 2013
End Date
January 10 2014
Last Update
August 30 2019
Active Locations (1)
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1
Bausch & Lomb Incorporated
Irvine, California, United States, 92618