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

Sponsor

Ophthalmic Consultants of Long Island (Other)

Overall Status

Completed

CT.gov ID

NCT00407043

Collaborator

Bausch & Lomb Incorporated (Industry)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease Keratoconjunctivitis Sicca	Drug: Lotemax Drug: Restasis	Phase 4

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 one out of every five Americans.

A growing body of evidence has associated ocular inflammation with the signs and symptoms of dry eye.

Restasis is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with a condition called keratoconjunctivitis sicca. The relief of dry eye signs and symptoms with Restasis therapy is often delayed by 1 to 6 months from the initiation of therapy. Stinging on installation, particularly when initiating therapy, has been reported.

Lotemax, an ophthalmic corticosteroid, targets inflammation with a unique, site-active mechanism of action.Structural modifications associated with an ester ophthalmic steroid make Lotemax highly lipid soluble, enhancing penetration into cells and enabling Lotemax to exert anti-inflammatory activity within the eye. Lotemax is indicated for the treatment of steroid responsive inflammatory conditions associated with the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Prospective, Multicenter, Randomized Controlled Study of the Effect of Lotepredol Etabonate on The Initiation of Dry Eye Treatment With Topical Cyclosporine

Study Start Date :

Nov 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Ocular Surface Disease Questionnnaire Results []
Lissamine green staining []
Fluorescein Staining []
Schirmer testing []

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.