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| Tracking Information | |||||||||
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| First Received Date † | June 20, 2008 | ||||||||
| Last Updated Date | June 23, 2008 | ||||||||
| Start Date † | June 2007 | ||||||||
| Current Primary Outcome Measures † |
Corneal and conjunctival staining score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures † | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00704275 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures † |
Schirmer 1 score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures † | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title † | Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes | ||||||||
| Official Title † | Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes | ||||||||
| Brief Summary | To compare the efficacy, safety and tolerability of 0.05% topical cyclosporin eye drop to Refresh in moderate to severe dry eye patients. Null hypothesis is: there is no difference between these two groups. |
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| Detailed Description | Inclusion criteria:
Outcome measurements: Main parameter is staining score (corneal + conjunctival) Other parameter is OSDI score, symptom of ocular surface discomfort score, number of daily artificial tear needed, TBUT, Schirmer I score, cytokines level & markers Safety parameters: VA, IOP, cyclosporin level |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition † | Dry Eye | ||||||||
| Intervention † | Drug: 0.05% cyclosporin eye drop | ||||||||
| 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 † | Recruiting | ||||||||
| Enrollment † | 60 | ||||||||
| Estimated Completion Date | October 2008 | ||||||||
| Estimated Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | Thailand | ||||||||
| Expanded Access Status | |||||||||
| Administrative Information | |||||||||
| NCT ID † | NCT00704275 | ||||||||
| Responsible Party | Vilavun Puangsricharern/Ass. Prof in Ophthalmology, Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Chulalongkorn University | ||||||||
| Collaborators †† | Allergan | ||||||||
| Investigators † | |||||||||
| Information Provided By | Chulalongkorn University | ||||||||
| Verification Date | June 2008 | ||||||||
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† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |
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