Overview

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.