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CompletedNCT06364943Updated Aug 29, 2025

Tear Ferning Test for Dry Eye Diagnosis

An interventional study of with/without dry eye syndrome in Dry Eye Syndromes, sponsored by Chung Shan Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by Chung Shan Medical University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

Application of tear ferning test for clinical dry eye diagnosis

Read the detailed description

Comparing dry eye patients' tear ferning structure with non-dry eye patients' to develop a protocol for easy and costless diagnosis in ophthalmology.

02

Conditions studied

  • Dry Eye Syndromes

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Keywords

  • Dry Eye diagnosis
  • Tear ferning
03

In context

Dry Eye Syndromes

1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.

This study's enrollment of 26 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.

Browse Dry Eye Syndromes studies →

Lead sponsor

Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • No intervention
    Dry eye patients

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

  • Other
    Non-Dry eye patients

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

    Other: with/without dry eye syndrome

Interventions

  • Otherwith/without dry eye syndrome

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

06

What researchers measure

Primary outcomes

  1. Schirmer's test

    to assess tear secretion volume

    Time frame: 5 minutes

  2. Tear film breakup time

    to assess tear quality

    Time frame: 20 seconds

  3. Ocular surface health evaluate

    To assess the health status with Lissamine green stain

    Time frame: 3 minutes

Secondary outcomes

  1. Ocular surface disease index

    A questionnaire to assess the health status on ocular surface A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.

    Time frame: 20 minutes

  2. Intraocular pressure

    to determine the effects of intervention on intraocular pressure

    Time frame: 2 minutes

07

Study locations

1 site
  • Jen-Ai Hospital
    Taichung, 412, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06364943
Lead sponsor
Chung Shan Medical University
Responsible party
David Pei-Cheng Lin (Chung Shan Medical University, Chung Shan Medical University) — Principal investigator
First posted
Apr 15, 2024
Start date
Apr 5, 2024
Primary completion
May 22, 2024
Completion
May 22, 2024
Last update
Aug 29, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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