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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ophthalmic Consultants of Long Island
• Collaborator: Bausch & Lomb Incorporated
• Treatments: Cyclosporine; Cyclosporins; Loteprednol Etabonate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.