Investigation on Medical Management of Dry Eye Patients

Completed

• Conditions: Dry Eye Syndrome

• Registration Number: NCT01942226
• Lead Sponsor: National Cheng Kung University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-10
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-13
• Primary Completion: 2013-11
• Status Verified: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-06
• Last Update Posted: 2013-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 466

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Artificial tears utilization patterns	within 1 month before recruitment

Secondary Outcome Measures

Name	Time	Method
Changes of dry eye symptoms, evaluated by clinicians	Baseline	Measured by clinical global impression (CGI)
Changes of dry eye symptoms, evaluated by patients	Baseline	Measured by subject global assessment (SGA)

Trial Locations

Locations (2)

Sun-Huei Tseng Eye Institute; 🇨🇳 Tainan, Taiwan

Department of Ophthalmology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan