Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis

Completed · Phase 4

Conditions studied: Dry Eye Disease, Keratoconjunctivitis Sicca

In brief

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 cyclosporine administration and the dry eye signs and symptoms experienced during the initiation of therapy.

Key facts

Study ID

NCT00407043

Run by

Ophthalmic Consultants of Long Island

People needed

5

Starts

2006-11-01

Expected to finish

2007-09-01

Last updated by the study team

2011-07-21

Who can join

Age: 30 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ophthalmic Consultants of Long Island — Lynbrook, New York, United States

Full record on ClinicalTrials.gov

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