Dry Eye SyndromesNCT06364943
Tear Ferning Test for Dry Eye Diagnosis
A study testing with/without dry eye syndrome in people with Dry Eye Syndromes, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
Application of tear ferning test for clinical dry eye diagnosis Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- with/without dry eye syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Apr 2024to 22 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Tear Ferning Test for Clinical Dry Eye Diagnosis
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.
- Conditions
- Dry Eye Syndromes
- Being tested
- with/without dry eye syndrome
- Keywords
- Dry Eye diagnosis, Tear ferning
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with/without dry eye syndromeOther
compare tear ferning structure between dry eye and non-dry eye patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: with/without dry eye syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer's test
to assess tear secretion volume
Measured: 5 minutes
Tear film breakup time
to assess tear quality
Measured: 20 seconds
Ocular surface health evaluate
To assess the health status with Lissamine green stain
Measured: 3 minutes
Secondary outcomes (2)
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.
Measured: 20 minutes
Intraocular pressure
to determine the effects of intervention on intraocular pressure
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start5 Apr 2024
- Primary completion22 May 2024
- Study completion22 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Pei-Cheng Lin, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364943
- Sponsor's protocol ID
- 202400020B0
- Status last verified
- Aug 2025
- First submitted
- 8 Apr 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Tear Ferning Test for Clinical Dry Eye Diagnosis
- ClinicalTrials.gov ID
- NCT06364943
- Acronym / sponsor ID
- 202400020B0
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye diagnosis, Tear ferning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 22 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Application of tear ferning test for clinical dry eye diagnosis
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry eye patients | No intervention | –Collect clinical information and tear samples from patients with dry eye syndrome. |
| Non-Dry eye patients | Other | Other: with/without dry eye syndromeCollect clinical information and tear samples from patients without dry eye syndrome. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| with/without dry eye syndromecompare tear ferning structure between dry eye and non-dry eye patients | Other | Non-Dry eye patients |
Primary outcome
Schirmer's test
Time frame: 5 minutes
to assess tear secretion volume
Tear film breakup time
Time frame: 20 seconds
to assess tear quality
Ocular surface health evaluate
Time frame: 3 minutes
To assess the health status with Lissamine green stain
2 secondary outcomes
Ocular surface disease index
Time frame: 20 minutes
Intraocular pressure
Time frame: 2 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing with/without dry eye syndrome in people with Dry Eye Syndromes, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schirmer's test (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.