NCT06364943

Brief Summary

Application of tear ferning test for clinical dry eye diagnosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

April 5, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2024

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

April 8, 2024

Last Update Submit

August 24, 2025

Conditions

Dry Eye Syndromes

Keywords

Dry Eye diagnosisTear ferning

Outcome Measures

Primary Outcomes (3)

  • Schirmer's test

    to assess tear secretion volume

    5 minutes

  • Tear film breakup time

    to assess tear quality

    20 seconds

  • Ocular surface health evaluate

    To assess the health status with Lissamine green stain

    3 minutes

Secondary Outcomes (2)

  • Ocular surface disease index

    20 minutes

  • Intraocular pressure

    2 minutes

Study Arms (2)

Dry eye patients

NO INTERVENTION

Collect clinical information and tear samples from patients with dry eye syndrome.

Non-Dry eye patients

OTHER

Collect clinical information and tear samples from patients without dry eye syndrome.

Other: with/without dry eye syndrome

Interventions

with/without dry eye syndromeOTHER

compare tear ferning structure between dry eye and non-dry eye patients

Non-Dry eye patients

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 20 and 65 years
  • For dry eye disease group:
  • Schirmer's test results between 5 - 10 mm
  • Tear Film Break Up Time less than 10 seconds
  • Ocular Surface Disease Index of more than 25

You may not qualify if:

  • Those have diabetes, hypertension or other chronic diseases
  • No evident ocular diseases such as cornea disease, cataracts, vitreous degeneration, glaucoma, and retinopathy.
  • Belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jen-Ai Hospital

Taichung, 412, Taiwan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chung Shan Medical University

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 15, 2024

Study Start

April 5, 2024

Primary Completion

May 22, 2024

Study Completion

May 22, 2024

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)