NCT05096546

Brief Summary

The study aims to determine the proportion of patients diagnosed with dry eye by the Asia Dry Eye Society (ADES) criteria, among patients diagnosed with dry eye disease under current hospital-based practice in Taiwan.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

October 5, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

October 21, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

October 5, 2021

Last Update Submit

May 25, 2022

Conditions

Dry Eye Syndromes

Keywords

Dry eye diseaseAsia Dry Eye Society (ADES) criteriaTaiwanese population

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients who satisfy the criteria for dry eye disease based on the ADES criteria

    The criteria are defined by Asia Dry Eye Society (ADES).

    At the time of dry eye diagnosis (baseline)

Secondary Outcomes (19)

  • Proportion of patients per dry eye severity

    From baseline to 6-month follow-up

  • Proportion of patients per dry eye classification

    From baseline to 6-month follow-up

  • Length (mm) of soaked strip by tear for the dry eye diagnosis

    From baseline to 6-month follow-up

  • Time (second) for tear film broken with fluorescein for the dry eye diagnosis

    From baseline to 6-month follow-up

  • Score of Ocular Surface Disease Index (OSDI) for the dry eye symptoms

    From baseline to 6-month follow-up

  • +14 more secondary outcomes

Study Arms (2)

Group I

1. 20 years old or older (regardless of sex) 2. Outpatients 3. Newly-diagnosed with dry eye disease (DED) within 6 months prior to signing the informed consent under hospital-based practice in Taiwan

Other: No intervention

Group II

1. 20 years old or older (regardless of sex) 2. Outpatients 3. Patients who had undergone cataract surgery and 1. was suspected to have dry eye disease (dry eye evaluations conducted based on the routine practice) within 6 months prior to signing the informed consent or 2. was diagnosed with dry eye disease within 6 months prior to signing the informed consent

Other: No intervention

Interventions

No interventionOTHER

No intervention will be applied for the observational study.

Group IGroup II

Eligibility Criteria

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

These patients will be screened in the outpatient department at Far Eastern Memorial Hospital, Kaohsiung Medical University Hospital, and Taipei Veteran General Hospital.

You may qualify if:

  • Patients who meet the criteria of either Group I OR Group II are eligible.
  • Group I
  • Patients with signed informed consent and who satisfy all of the following criteria will be included:
  • years old or older (regardless of sex)
  • Outpatients
  • Newly-diagnosed with dry eye disease (DED) within 6 months prior to signing the informed consent under hospital-based practice in Taiwan
  • Group II
  • Patients with signed informed consent and who satisfy all of the following criteria will be included:
  • years old or older (regardless of sex)
  • Outpatients
  • Patients who had undergone cataract surgery and
  • was suspected to have dry eye disease (dry eye evaluations conducted based on the routine practice) within 6 months prior to signing the informed consent or
  • was diagnosed with dry eye disease within 6 months prior to signing the informed consent

You may not qualify if:

  • Patients who meet ANY one of the following criteria are not eligible.
  • Patients who have ocular comorbidities, and appear dry eye sign and symptoms that interfere with diagnosis of dry eye disease (DED)
  • Patients who cannot confirm subjective symptoms of dry eye
  • Patients who cannot read or write, and/or could not understand dry eye questionnaire appropriately which may compromise the accuracy of questionnaire score.
  • Patients who participate in other interventional trials in the past 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

Far Eastern Memorial Hospital

New Taipei City, Taiwan

Location

Taipei Veteran General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

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

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 27, 2021

Study Start

October 21, 2021

Primary Completion

February 28, 2022

Study Completion

July 31, 2022

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(3)