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NCT01942226 Clinical Trial

Investigation on Medical Management of Dry Eye Patients

Dry Eye Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01942226
Other study ID # MODE
Secondary ID
Status Completed
Phase N/A
First received September 10, 2013
Last updated December 6, 2013
Start date August 2013
Est. completion date December 2013

Study information
Verified date December 2013
Source National Cheng Kung University
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

Dry eye is a common complaint in patients encountered by ophthalmologists, which may result from the inflammatory response and can occur in the absence of systemic disease. However, the management of dry eye syndrome in real setting warrants assessment but remains lacking in Taiwan. We conducted an perspective observational study to evaluate the medical management of dry eye patients.

Recruitment information / eligibility
Status Completed
Enrollment 466
Est. completion date December 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Have given a written informed consent

- Clinical diagnosis of dry eye syndrome

- Have at least one Schirmer's test positive result (less than 10mm/5min) in at least one eye within one year

Exclusion Criteria:

- Pregnancy

- Cognitive or psychiatric deficit that precludes informed consent

- Cognitive or psychiatric deficit that precludes ability to perform requirements of the investigation

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Sun-Huei Tseng Eye Institute Tainan
Taiwan Department of Ophthalmology, National Taiwan University Hospital Taipei

Sponsors (5)
Lead Sponsor Collaborator
National Cheng Kung University Allergan Pharmaceuticals Taiwan Co., Ltd., Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University, Tainan, Taiwan, National Taiwan University Hospital, Sun-Huei Tseng Eye Institute

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Artificial tears utilization patterns within 1 month before recruitment No
Secondary Changes of dry eye symptoms, evaluated by clinicians Measured by clinical global impression (CGI) Baseline No
Secondary Changes of dry eye symptoms, evaluated by patients Measured by subject global assessment (SGA) Baseline No
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