The Proportion of Patients Diagnosed With Dry Eye by the Asia Dry Eye Society (ADES) Criteria in Taiwan (DECS-TW) (DECS-TW)

Dry Eye Cross-Sectional Study-Taiwan (DECS-TW): Observational, Multicenter, Cross-Sectional Study on Dry Eye Disease in Taiwan

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Other: No intervention

Detailed Description

This real-world, observational study aims to show in a descriptive manner to characterize the patient profile of dry eye disease in Taiwan, and to understand the local practice and its difference compared with Asia Dry Eye Society (ADES) criteria. Specific objectives include:(1) 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, (2) to compare the patient profile including ocular condition and dry eye-related characteristics of dry eye diagnosed with ADES criteria versus hospital-based real-world practice in Taiwan, and (3) to determine the disease characteristics of patients diagnosed with dry eye in Taiwan medical institutions.

This study will enroll patients who are diagnosed with dry eye, aged 20 years (inclusive), and are willing to provide signed informed consent. These patients will be categorized into Group I or II according to the inclusion criteria.

Clinical data of eligible patients at the time of dry eye diagnosis on medical charts will be collected. If any return visit is scheduled per routine practice before the end of data collection (Feb-28-2022), follow-up data regarding dry eye evaluations and treatments will be collected at the first follow-up visit for Group I; and within 6 months after the cataract surgery for Group II.

• Study Type: Observational
• Enrollment (Anticipated): 540

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung city, Taiwan
    • Kaohsiung Medical University Hospital
  • New Taipei City, Taiwan
    • Far Eastern Memorial Hospital
  • Taipei City, Taiwan
    • Taipei Veteran General Hospital

Participation Criteria

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

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

Description

Inclusion Criteria:

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:

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

Group II

Patients with signed informed consent and who satisfy all of the following criteria will be included:

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

Exclusion Criteria:

Patients who meet ANY one of the following criteria are not eligible.

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; 20 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	Other: No intervention; No intervention will be applied for the observational study.
Group II; 20 years old or older (regardless of sex); Outpatients; Patients who had undergone cataract surgery andwas suspected to have dry eye disease (dry eye evaluations conducted based on the routine practice) within 6 months prior to signing the informed consent orwas diagnosed with dry eye disease within 6 months prior to signing the informed consent	Other: No intervention; No intervention will be applied for the observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients per dry eye severity	Dry eye severity (mild, moderate, severe) is judged by the investigator.	From baseline to 6-month follow-up
Proportion of patients per dry eye classification	Dry eye classification is judged by the investigator.	From baseline to 6-month follow-up
Length (mm) of soaked strip by tear for the dry eye diagnosis	Unanesthetized Schirmer's test is used for assessing the tear production.	From baseline to 6-month follow-up
Time (second) for tear film broken with fluorescein for the dry eye diagnosis	Tear break-up time (TBUT) is used to assess for tear film (evaporative dry eye disease).	From baseline to 6-month follow-up
Score of Ocular Surface Disease Index (OSDI) for the dry eye symptoms	Ocular Surface Disease Index (OSDI) questionnaire (0 to 100 points) is used to assess the dry eye symptoms. One hundred points mean that the dry eye disease of the patient is severe.	From baseline to 6-month follow-up
Score of Standard Patient Evaluation of Eye Dryness (SPEED) for the dry eye symptoms	Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (0 to 28 points) is used to assess the dry eye symptoms. Twenty-eight points mean that the symptoms of dry eye disease is severe.	From baseline to 6-month follow-up
Visual analogue scale (VAS) for the dry eye severity	Visual analogue scale (VAS) (0 to 10 [mild to severe]) is used to assess the dry eye severity based on the symptoms.	From baseline to 6-month follow-up
Difference in length (mm) of soaked strip by tear between patients who satisfy the criteria for dry eye disease based on the ADES consensus report and the whole population (i.e., hospital-based real-world practice)	Unanesthetized Schirmer's test is used for assessing the tear production.	At the time of dry eye diagnosis (baseline)
Difference in time (second) for tear film broken with fluorescein between patients who satisfy the criteria for dry eye disease based on the ADES consensus report and the whole population (i.e., hospital-based real-world practice)	Tear break-up time (TBUT) is used to assess for tear film (evaporative dry eye disease).	At the time of dry eye diagnosis (baseline)
Difference in score of Ocular Surface Disease Index (OSDI) between patients who satisfy the criteria for dry eye disease based on the ADES consensus report and the whole population (i.e., hospital-based real-world practice)	Ocular Surface Disease Index (OSDI) questionnaire (0 to 100 points) is used to assess the dry eye symptoms. One hundred points mean that the dry eye disease of the patient is severe.	At the time of dry eye diagnosis (baseline)
Difference in score of Standard Patient Evaluation of Eye Dryness (SPEED) between patients who satisfy the criteria for dry eye disease based on the ADES consensus report and the whole population (i.e., hospital-based real-world practice)	Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (0 to 28 points) is used to assess the dry eye symptoms. Twenty-eight points mean that the symptoms of dry eye disease is severe.	At the time of dry eye diagnosis (baseline)
Difference in visual analogue scale (VAS) between patients who satisfy the criteria for dry eye disease based on the ADES consensus report and the whole population (i.e., hospital-based real-world practice)	Visual analogue scale (VAS) (0 to 10 [mild to severe]) is used to assess the dry eye severity based on symptoms.	At the time of dry eye diagnosis (baseline)
Proportion of patients who do not satisfy the criteria for dry eye disease based on the ADES per dry eye severity	Dry eye severity (mild, moderate, severe) is judged by the investigator.	From baseline to 6-month follow-up
Proportion of patients who do not satisfy the criteria for dry eye disease based on the ADES per dry eye classification	Dry eye classification is judged by the investigator.	From baseline to 6-month follow-up
Length (mm) of soaked strip by tear using unanesthetized Schirmer test of patients who do not satisfy the criteria for dry eye disease based on the ADES	Schirmer's test is used for assessing the tear production.	From baseline to 6-month follow-up
Time (second) for tear film broken with fluorescein of patients who do not satisfy the criteria for dry eye disease based on the ADES	Tear break-up time (TBUT) is used to assess for tear film (evaporative dry eye disease).	From baseline to 6-month follow-up
Score of Ocular Surface Disease Index (OSDI) of patients who do not satisfy the criteria for dry eye disease based on the ADES	Ocular Surface Disease Index (OSDI) questionnaire (0 to 100 points) is used to assess the dry eye symptoms. One hundred points mean that the dry eye disease of the patient is severe.	From baseline to 6-month follow-up
Score of Standard Patient Evaluation of Eye Dryness (SPEED) of patients who do not satisfy the criteria for dry eye disease based on the ADES	Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire (0 to 28 points) is used to assess the dry eye symptoms. Twenty-eight points mean that the symptoms of dry eye disease is severe.	From baseline to 6-month follow-up
Visual analogue scale (VAS) of patients who do not satisfy the criteria for dry eye disease based on the ADES	Visual analogue scale (VAS) (0 to 10 [mild to severe]) is used to assess the dry eye severity based on the symptoms.	From baseline to 6-month follow-up

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Collaborators: Taipei Veterans General Hospital, Taiwan; Kaohsiung Medical University; Santen Pharmaceutical (Taiwan) Co., LTD

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 21, 2021
• Primary Completion (ACTUAL): February 28, 2022
• Study Completion (ANTICIPATED): July 31, 2022

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (ACTUAL): October 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Dry eye disease; Asia Dry Eye Society (ADES) criteria; Taiwanese population
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: FOTE-DE-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No