Status:
COMPLETED
Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis
Lead Sponsor:
Ophthalmic Consultants of Long Island
Collaborating Sponsors:
Bausch & Lomb Incorporated
Conditions:
Dry Eye Disease
Keratoconjunctivitis Sicca
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry eye. It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the stinging with...
Detailed Description
Dry eye is an ocular surface disease that produces discomfort and irritation. Estimated prevalence ranges from 20 million people in the US being affected with mild to moderate dry eye, to as many as o...
Eligibility Criteria
Inclusion
- Between the ages of 30 and 80 inclusive.
- Has not worn contact lenses for at least 1 month prior to the study and agrees to not wear contact lenses during study.
- Oral medications stable 1 month prior to study.
- Oral medications anticipated to be stable during 60 day study.
- Patient is in generally good \& stable overall health.
- Patient likely to comply with eye drop regimen, study guidelines \& study visits.
- Corneal stain \> 1+ or Conjunctival stain \> 1+ or OSDI equal or \> 5 or using regular artificial tears at least on average twice daily.
- Informed consent signed.
Exclusion
- History of Stevens-Johnson Syndrome or Ocular Pemphigoid.
- Punctal plugs inserted or punctal cautery in the past 3 months.
- Intra-ocular surgery within 6 months or ocular laser surgery within 3 months.
- History of liver disease.
- Pregnant or lactating women.
- Severe clinical vitamin deficiencies or history of vitamin overdose.
- Highly variable vitamin intake.
- Unstable use of systemic or topical medications known to create dry eye.
- Corneal pathology, which could, of itself, cause an ocular surface disorder.
- Use of glaucoma medications, topical or oral.
- Unstable diabetes mellitus.
- Allergy or sensitivity to Lotemax, Restasis or the OTC Tear Supplement.
- Use of topical steroids or Restasis within the past 1 month.
- Use of other topical ocular agents other than tear replacements within the past 1 week.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00407043
Start Date
November 1 2006
End Date
September 1 2007
Last Update
July 21 2011
Active Locations (1)
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1
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States, 11563