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| Sponsored by: |
Innovative Medical |
| Information provided by: | Innovative Medical |
| ClinicalTrials.gov Identifier: | NCT00567983 |
Purpose
The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.
| Condition | Intervention | Phase |
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Disease Progression Disease Severity Staining Schirmers OSDI |
Drug: Restasis Drug: Endura |
Phase IV |
| ChemIDplus related topics: | Cyclosporine Cyclosporin |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
| Official Title: | Topical Cyclosporine and Disease Progression |
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1.: Active Comparator |
Drug: Restasis
Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
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| 2.: Placebo Comparator |
Drug: Endura
Restasis- (in the eye) Instill one drop twice daily Endura- (in the eye) Instill one drop twice daily
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Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Lakeside Eye Clinic ( Sanjay Rao, MD ) |
| Study ID Numbers: | 13717A |
| First Received: | December 3, 2007 |
| Last Updated: | September 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00567983 |
| Health Authority: | United States: Institutional Review Board |
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