NCT01942226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
466

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 9, 2013

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

September 10, 2013

Last Update Submit

December 6, 2013

Conditions

Dry Eye Syndrome

Keywords

Dry eye syndrome

Outcome Measures

Primary Outcomes (1)

  • Artificial tears utilization patterns

    within 1 month before recruitment

Secondary Outcomes (2)

  • Changes of dry eye symptoms, evaluated by clinicians

    Baseline

  • Changes of dry eye symptoms, evaluated by patients

    Baseline

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants from a primary care clinic or a tertiary referral center

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Cognitive or psychiatric deficit that precludes informed consent
  • Cognitive or psychiatric deficit that precludes ability to perform requirements of the investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sun-Huei Tseng Eye Institute

Tainan, 704, Taiwan

Location

Department of Ophthalmology, National Taiwan University Hospital

Taipei, 101, Taiwan

Location

Related Publications (1)

  • Yeh PT, Chien HC, Ng K, Tseng SH, Chen WL, Hou YC, Wang IJ, Chu HS, Kao Yang YH, Hu FR. Concordance between patient and clinician assessment of dry eye severity and treatment response in Taiwan. Cornea. 2015 May;34(5):500-5. doi: 10.1097/ICO.0000000000000409.

    PMID: 25782401DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Yea-Huei Kao Yang, Professor

    Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

December 9, 2013

Record last verified: 2013-12

Locations

TW(2)