Dry Eye Disease Clinical Trial
Official title:
A Prospective, Multicenter, Randomized Controlled Study of the Effect of Lotepredol Etabonate on The Initiation of Dry Eye Treatment With Topical Cyclosporine
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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