Investigation on Medical Management of Dry Eye Patients

December 6, 2013 updated by: Yea-Huei Kao Yang, National Cheng Kung University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

466

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • Sun-Huei Tseng Eye Institute
      • Taipei, Taiwan, 101
        • Department of Ophthalmology, National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants from a primary care clinic or a tertiary referral center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Artificial tears utilization patterns
Time Frame: within 1 month before recruitment
within 1 month before recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of dry eye symptoms, evaluated by clinicians
Time Frame: Baseline
Measured by clinical global impression (CGI)
Baseline
Changes of dry eye symptoms, evaluated by patients
Time Frame: Baseline
Measured by subject global assessment (SGA)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng Kung University

Collaborators

National Taiwan University Hospital
Sun-Huei Tseng Eye Institute
Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University, Tainan, Taiwan
Allergan Pharmaceuticals Taiwan Co., Ltd.

Investigators

  • Principal Investigator: Yea-Huei Kao Yang, Professor, Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Estimate)

December 9, 2013

Last Update Submitted That Met QC Criteria

December 6, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MODE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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