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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 30, 2007 | ||||||||
| Last Updated Date | September 23, 2008 | ||||||||
| Start Date ICMJE | November 2007 | ||||||||
| Current Primary Outcome Measures ICMJE |
Dry Eye disease [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00567177 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease | ||||||||
| Official Title ICMJE | Objective Measurements of Prolonged Effects of Restasis on Dry Eye Disease | ||||||||
| Brief Summary | We propose to investigate the response to Restasis, over a prolonged period of time in heavy computer users with dry eye disease. |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment | ||||||||
| Condition ICMJE | Treatment of Dry Eye Disease | ||||||||
| Intervention ICMJE | Drug: Restasis, Refresh Plus | ||||||||
| Study Arms / Comparison Groups | |||||||||
| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | April 2008 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 13 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00567177 | ||||||||
| Responsible Party | Richard Yee, MD, Hermann Eye Center | ||||||||
| Study ID Numbers ICMJE | HSC-MS-07-0421 | ||||||||
| Study Sponsor ICMJE | Innovative Medical | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Innovative Medical | ||||||||
| Verification Date | September 2008 | ||||||||
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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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