NCT00407043

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Ophthalmic Consultants of Long Island · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Dry Eye Disease
• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DRUG	Lotemax
DRUG	Restasis

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2006-12-04
• Last updated: 2011-07-21

Locations

1 site across 1 country: United States