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| Tracking Information | |
|---|---|
| First Received Date ICMJE | February 29, 2008 |
| Last Updated Date | October 2, 2009 |
| Start Date ICMJE | February 2008 |
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Change in levels of biomarkers after dosing with Maxidex [ Time Frame: After 2 weeks on treatment ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00631358 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Correlation between biomarker expression, and corneal staining, tear film break up time and ocular symptoms [ Time Frame: After 2 weeks of treatment ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention (JADE2) |
| Official Title ICMJE | |
| Brief Summary | The primary purpose of this study is to quantify the change in expression of biomarkers on the ocular surface of Sjogren's Syndrome participants after treatment with Maxidex. |
| Detailed Description | |
| Study Phase | Phase IV |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment |
| Condition ICMJE | Sjogren's Syndrome |
| Intervention ICMJE | Drug: 0.1% Dexamethasone (Maxidex) |
| Study Arms / Comparison Groups |
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| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 90 |
| Completion Date | |
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria of Sjorgren's Population: Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 17 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Canada |
| Administrative Information | |
| NCT ID ICMJE | NCT00631358 |
| Responsible Party | Ravaughn Williams, OD, MS, Alcon |
| Study ID Numbers ICMJE | ORE 14351 |
| Study Sponsor ICMJE | Alcon Research |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Alcon Research |
| Verification Date | October 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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