Dry Eye DiseaseNCT07363824
A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.
An observational study of Dry Eye Disease and Iron, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
This study aims to see if the amount of iron in tears is linked to how severe dry eye disease is. We hope this can lead to a new way to help diagnose and understand dry eye. This is an observational study. We will compare tear samples from people with dry eye to samples from people with healthy eyes. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease, Iron
- What is being tested?
- Diagnostic tear fluid collection and ocular surface evaluation
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2026to May 2029
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Based on your study protocol, here is the description for the "Study Population Description" field: This single-center, cross-sectional study will recruit participants from the patient population and staff/community at the Ophthalmology Department of Shanghai Changzheng Hospital. The Dry Eye Disease (DED) group will consist of consecutive patients presenting to the clinic who are diagnosed with DED according to the 2024 Chinese Expert Consensus criteria. The healthy control group will be recruited through hospital staff volunteers and community advertisements. All participants will be enrolled during the specified study period from the single site.
Who may be able to join
- Aged between 18 and 70 years, inclusive.
- Willing and able to provide written informed consent.
Who cannot join
- History or clinical suspicion of significant systemic conditions: hematologic diseases, severe systemic infections, malignancies (treated or untreated), or chronic hepatic/renal insufficiency.
- Use of artificial tears or any topical eye drops within 2 hours prior to examination.
- Active ocular allergy, infection, or severe blepharitis within the past 1 month.
- Systemic or topical use of antibiotics, corticosteroids, NSAIDs, or immunosuppressants within the past 1 month.
- History of contact lens wear within the past 1 month.
- History of blood transfusion, ocular surgery, or significant ocular trauma within the past 6 months.
- Women who are pregnant, breastfeeding, or postmenopausal women undergoing hormone replacement therapy.
- Known hypersensitivity to fluorescein sodium.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changzheng Hospital
Shanghai
Chunhui Yang, 021-66540109, 1633810781@qq.com
About this study
This study aims to see if the amount of iron in tears is linked to how severe dry eye disease is. We hope this can lead to a new way to help diagnose and understand dry eye. This is an observational study. We will compare tear samples from people with dry eye to samples from people with healthy eyes. We will measure the iron content in the tears and see if it correlates with standard dry eye test results and symptom scores.
- Conditions
- Dry Eye Disease, Iron
- Being tested
- Diagnostic tear fluid collection and ocular surface evaluation
- Keywords
- DED, iron
- 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.
Diagnostic tear fluid collection and ocular surface evaluationProcedure or surgery
This is an observational study; no therapeutic intervention is administered. All participants undergo a single, standardized study visit that includes:
Tear Fluid Collection: Tear samples are collected using sterile Schirmer test strips (without anesthesia) placed in the lower conjunctival sac for 5 minutes.
Comprehensive Ocular Surface Evaluation:
Symptom Assessment: Completion of the Ocular Surface Disease Index (OSDI) questionnaire.
Clinical Tests: Measurement of fluorescein tear film breakup time (FBUT), corneal fluorescein staining (CFS) scoring, and Schirmer I test.
The collected tear samples are subsequently analyzed for iron concentration. All procedures are diagnostic and evaluative in nature.
| Study group | Role | What they receive |
|---|---|---|
| CON | Not described Receives: Procedure: Diagnostic tear fluid collection and ocular surface evaluation | |
| DED | Not described Receives: Procedure: Diagnostic tear fluid collection and ocular surface evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between tear fluid iron concentration and dry eye symptom severity
The strength of association between the concentration of iron (in μg/mL) in tear fluid collected via Schirmer strips and the total score on the Ocular Surface Disease Index (OSDI) questionnaire.
Measured: baseline
Secondary outcomes (3)
Correlation between tear fluid iron concentration and tear film stability
The correlation between tear iron concentration and fluorescein tear film breakup time (FBUT) measured in seconds.
Measured: baseline
Correlation between tear fluid iron concentration and tear secretion volume
The correlation between tear iron concentration and the result of the Schirmer I test (without anesthesia) measured in millimeters of wetting over 5 minutes.
Measured: baseline
Correlation between tear fluid iron concentration and corneal epithelial damage
The correlation between tear iron concentration and the Corneal Fluorescein Staining (CFS) score, a standardized clinical grading of epithelial damage.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start6 Feb 2026
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruili Wei, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363824
- Sponsor's protocol ID
- DED-A
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.
- ClinicalTrials.gov ID
- NCT07363824
- Acronym / sponsor ID
- DED-A
- Conditions
- Dry Eye Disease, Iron
- Keywords
- DED, iron
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 23 Jan 2026 (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.
This study aims to see if the amount of iron in tears is linked to how severe dry eye disease is. We hope this can lead to a new way to help diagnose and understand dry eye. This is an observational study. We will compare tear samples from people with dry eye to samples from people with healthy eyes. We will measure the iron content in the tears and see if it correlates with standard dry eye test results and symptom scores.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CON | – | Procedure: Diagnostic tear fluid collection and ocular surface evaluation |
| DED | – | Procedure: Diagnostic tear fluid collection and ocular surface evaluation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Based on your study protocol, here is the description for the "Study Population Description" field: This single-center, cross-sectional study will recruit participants from the patient population and staff/community at the Ophthalmology Department of Shanghai Changzheng Hospital. The Dry Eye Disease (DED) group will consist of consecutive patients presenting to the clinic who are diagnosed with DED according to the 2024 Chinese Expert Consensus criteria. The healthy control group will be recruited through hospital staff volunteers and community advertisements. All participants will be enrolled during the specified study period from the single site.
Key inclusion criteria (2 listed)
- Aged between 18 and 70 years, inclusive.
- Willing and able to provide written informed consent.
Key exclusion criteria (8 listed)
- History or clinical suspicion of significant systemic conditions: hematologic diseases, severe systemic infections, malignancies (treated or untreated), or chronic hepatic/renal insufficiency.
- Use of artificial tears or any topical eye drops within 2 hours prior to examination.
- Active ocular allergy, infection, or severe blepharitis within the past 1 month.
- Systemic or topical use of antibiotics, corticosteroids, NSAIDs, or immunosuppressants within the past 1 month.
- History of contact lens wear within the past 1 month.
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 |
|---|---|---|
| Diagnostic tear fluid collection and ocular surface evaluationThis is an observational study; no therapeutic intervention is administered. All participants undergo a single, standardized study visit that includes: Tear Fluid Collection: Tear samples are collected using sterile Schirmer test strips (without anesthesia) placed in the lower conjunctival sac for 5 minutes. Comprehensive Ocular Surface Evaluation: Symptom Assessment: Completion of the Ocular Surface Disease Index (OSDI) questionnaire. Clinical Tests: Measurement of fluorescein tear film breakup time (FBUT), corneal fluorescein staining (CFS) scoring, and Schirmer I test. The collected tear samples are subsequently analyzed for iron concentration. All procedures are diagnostic and evaluative in nature. | Procedure or surgery | CON, DED |
Primary outcome
Correlation between tear fluid iron concentration and dry eye symptom severity
Time frame: baseline
The strength of association between the concentration of iron (in μg/mL) in tear fluid collected via Schirmer strips and the total score on the Ocular Surface Disease Index (OSDI) questionnaire.
3 secondary outcomes
Correlation between tear fluid iron concentration and tear film stability
Time frame: baseline
Correlation between tear fluid iron concentration and tear secretion volume
Time frame: baseline
Correlation between tear fluid iron concentration and corneal epithelial damage
Time frame: baseline
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 10 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease and Iron, run by Shanghai Changzheng Hospital at 1 site in China.
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 2 inclusion and 8 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 10 Feb 2026. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between tear fluid iron concentration and dry eye symptom severity (time frame: baseline). 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 10 Feb 2026.