Lotemax® Gel 0.5% and Restasis 0.05% in Subjects With Mild or Moderate Keratoconjunctivitis Sicca
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 11/30/2013 |
| Start Date: | May 2013 |
| Contact: | Mallory Peeler |
| Email: | Mallory.Peeler@Bausch.com |
| Phone: | (949) 788-5397 |
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)
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.
Inclusion Criteria:
- Have been diagnosed with or treated for keratoconjunctivitis sicca (dry eye
disease[DED]) within 6 months prior to Visit 1.
- Have a baseline (Visit 2) Intraocular pressure (IOP) measurement of ≥ 5 mmHg and ≤ 22
mmHg in each eye, with or without anti-glaucoma therapy.
- Have mild to moderate DED in one eye or both eyes at Visit 1 and Visit 2.
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 > 22 mm Hg in either
eye at the screening visit (Visit 1).
- 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 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.
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