Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00407043|
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : July 21, 2011
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|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 :||November 2006|
|Primary Completion Date :||September 2007|
|Study Completion Date :||September 2007|
- Ocular Surface Disease Questionnnaire Results
- Lissamine green staining
- Fluorescein Staining
- Schirmer testing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00407043
|United States, New York|
|Ophthalmic Consultants of Long Island|
|Lynbrook, New York, United States, 11563|
|Study Director:||Maria Howard||Ophthalmic Consultants of Long Island|