Dry Eye SyndromesNCT06848829
Difference of Tear Ferning Between Women with and Without Menopausal.
A study testing Pre-manepausal women 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 and menopause Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Pre-manepausal women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 20 and 65 years
Who cannot join
- No evident ocular diseases such as cornea, 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. Contact the study team or a site near you to ask about taking part.
Yiting Tian, Master contact
Taiwan1 site, 1 recruiting
- Recruiting
Jen-Ai Hospital
Taichung, Taiwan, 412
SHU-YAN PENG, Master, 886-933-854862
About this study
Official title: Difference of Tear Ferning Between Pre-and Post-menopausal Women and Between Post-menopausal Women with or Without Hormone Replacement Therapy (HRT)
Application of tear ferning test for clinical dry eye diagnosis and menopause
Read the detailed description
Analyzing the difference in tear ferning structure between women pre and post-menopause with and without hormone replacement therapy (HRT). Tear and blood samples were collected for a menopause-related Enzyme-linked immunosorbent assay. Tear volume, tear osmolarity, intraocular pressure, and tear break-up time were also measured for comparison.
- Conditions
- Dry Eye Syndromes
- Being tested
- Pre-manepausal women
- Keywords
- Dry Eye diagnosis, Tear ferning, menopause
- 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.
Pre-manepausal womenOther
Also called Post-manepausal women
Compare tear ferning structure between pre-menopause and post-menopause women.
| Study group | Role | What they receive |
|---|---|---|
| Pre-manepausal women | No intervention | Collect clinical information, tear and blood samples from women pre-menopause with dry eye syndrome. |
| Post-manepausal women | Other | Collect clinical information, tear and blood samples from women post-menopause with dry eye syndrome. Receives: Other: Pre-manepausal women |
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 status
To assess ocular surface health status with lissamine green stain, health or corneal abrasion.
Measured: 3 minutes
Tear ferning
crystal structure formed from tear drops on a slide be scored.
Measured: 30 minutes
Menopause related hormone Enzyme-linked immunosorbent assay (ELISA)
To assess FSH/LH/E2/Progesterone/Mc5AC/Lactoferrin concentration between pre- and post-manopause women.
Measured: 3 hours
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 posted27 Feb 2025
- Study start1 Oct 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848829
- Sponsor's protocol ID
- 202400071B0
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference of Tear Ferning Between Pre-and Post-menopausal Women and Between Post-menopausal Women with or Without Hormone Replacement Therapy (HRT)
- ClinicalTrials.gov ID
- NCT06848829
- Acronym / sponsor ID
- 202400071B0
- Conditions
- Dry Eye Syndromes
- Keywords
- Dry Eye diagnosis, Tear ferning, menopause
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 27 Feb 2025 (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 and menopause
Detailed description
Analyzing the difference in tear ferning structure between women pre and post-menopause with and without hormone replacement therapy (HRT). Tear and blood samples were collected for a menopause-related Enzyme-linked immunosorbent assay. Tear volume, tear osmolarity, intraocular pressure, and tear break-up time were also measured for comparison.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-manepausal women | No intervention | –Collect clinical information, tear and blood samples from women pre-menopause with dry eye syndrome. |
| Post-manepausal women | Other | Other: Pre-manepausal womenCollect clinical information, tear and blood samples from women post-menopause with dry eye syndrome. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged between 20 and 65 years
Key exclusion criteria (2 listed)
- No evident ocular diseases such as cornea, 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 |
|---|---|---|
| Pre-manepausal womenAlso: Post-manepausal womenCompare tear ferning structure between pre-menopause and post-menopause women. | Other | Post-manepausal women |
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 status
Time frame: 3 minutes
To assess ocular surface health status with lissamine green stain, health or corneal abrasion.
Tear ferning
Time frame: 30 minutes
crystal structure formed from tear drops on a slide be scored.
Menopause related hormone Enzyme-linked immunosorbent assay (ELISA)
Time frame: 3 hours
To assess FSH/LH/E2/Progesterone/Mc5AC/Lactoferrin concentration between pre- and post-manopause women.
2 secondary outcomes
Ocular surface disease index
Time frame: 20 minutes
Intraocular pressure
Time frame: 2 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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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.
Yiting Tian, Master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-manepausal women 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David P Lin, PhD (886-910-371286, pcl@csmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schirmer's test (time frame: 5 minutes). The study lists 5 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 27 Feb 2025.