GlaucomaNCT07119580
Association Between Limbal Function and Tear Proteomics in Chronic Ocular Diseases: Focusing on Glaucoma
An observational study of Glaucoma and Ocular Hypertension, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background Intact corneal epithelium is important for the defense on the ocular surface, and the function of limbal stem cells is crucial to maintain its integrity. Certain chronic eye diseases, such as glaucoma, require long-term medication use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Ocular Hypertension, Limbal Stem Cell Deficiency
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jul 2025to Dec 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Glaucoma patients in outpatient clinic setting.
Who may be able to join
- Age ≥ 18 years. ii. Healthy Control Group: No diagnosis of glaucoma or ocular hypertension. iii. Glaucoma, Newly Diagnosed Group: Diagnosed with angle-closure glaucoma, open-angle glaucoma, or ocular hypertension; antiglaucoma medication usage for less than 3 months.
- Glaucoma, Long-term Medication Group: Diagnosed with angle-closure glaucoma, open-angle glaucoma, or ocular hypertension; continuous use of intraocular pressure-lowering medications for more than 1 year.
- Glaucoma, Unilateral Group: Diagnosed with unilateral glaucoma or ocular hypertension; only one eye receiving intraocular pressure-lowering treatment.
Who cannot join
- History of severe ocular trauma, chemical burns, corneal ulcers, Stevens-Johnson syndrome with ocular involvement, or ocular graft-versus-host disease.
- History of corneal surgery, conjunctival surgery, trabeculectomy, or glaucoma drainage device implantation.
- Presence of ocular surface irregularity or limbal dysfunction due to conditions other than glaucoma or dry eye disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Hsinchu Branch
Hsinchu
Wei-Lun Huang, MD, +886-3-6677600 ext. 532267, weilunhuang@ntu.edu.tw
About this study
Background Intact corneal epithelium is important for the defense on the ocular surface, and the function of limbal stem cells is crucial to maintain its integrity. Certain chronic eye diseases, such as glaucoma, require long-term medication use. However, glaucoma patients often exhibit corneal punctate erosions and ocular surface inflammation. In cases where medication has been used for an extended period, patients may even show symptoms similar to limbal stem cell deficiency. Understanding how glaucoma medications affect the function of corneal limbal stem cells is a critical clinical issue.
Objectives To evaluate the effect of glaucoma and anti-glaucoma agents on corneal epithelial and limbal epithelial thickness as a surrogate of limbal stem cell function, and to understand the association between tear fluid proteome and limbal function in glaucoma patients.
Read more
Methods We planned to include 90 subjects with glaucoma, and analyze the absolute thickness and variation of corneal epithelium and limbal epithelium. Tear fluid samples will be collected and proteomic analysis will be performed to elucidate the association between protein.
Anticipated Results To elucidate the impact of different types and cumulative doses of glaucoma medications on the thickness of the corneal epithelium and limbal epithelium, and to understand the relationship between limbal function and tear proteomics in glaucoma patients. The expected results may help develop early detection methods for changes in corneal and limbal epithelial function and provide valuable insights for future research on drug design and the protection of limbal stem cells.
- Conditions
- Glaucoma, Ocular Hypertension, Limbal Stem Cell Deficiency
- Keywords
- Corneal epithelium, Limbal stem cells, Glaucoma, Tear fluid, Proteome
- Medical subject headings
- Glaucoma, Ocular Hypertension, Limbal Stem Cell Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | Healthy control, without diagnosis of glaucoma. | |
| Glaucoma, newly diagnosed | Glaucoma patients who received topical antiglaucoma medications for less than 3 months. | |
| Glaucoma, long-term medication use | Glaucoma patients, received topical antiglaucoma medications for 1 year or longer. | |
| Glaucoma, unilateral | Patients with unilateral glaucoma or ocular hypertension and received treatment only in the diseased eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limbal epithelial thickness
Limbal epithelial thickness obtained from AS-OCT
Measured: Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)
Secondary outcomes (2)
Corneal central epithelial thickness
Corneal epithelial thickness map obtained from AS-OCT
Measured: Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)
Proteomic findings of tear samples
Proteomic findings of tear samples
Measured: Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start8 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119580
- Sponsor's protocol ID
- 202407137RINB
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Limbal Function and Tear Proteomics in Chronic Ocular Diseases: Focusing on Glaucoma
- ClinicalTrials.gov ID
- NCT07119580
- Acronym / sponsor ID
- 202407137RINB
- Conditions
- Glaucoma, Ocular Hypertension, Limbal Stem Cell Deficiency
- Keywords
- Corneal epithelium, Limbal stem cells, Glaucoma, Tear fluid, Proteome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Aug 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.
Background Intact corneal epithelium is important for the defense on the ocular surface, and the function of limbal stem cells is crucial to maintain its integrity. Certain chronic eye diseases, such as glaucoma, require long-term medication use. However, glaucoma patients often exhibit corneal punctate erosions and ocular surface inflammation. In cases where medication has been used for an extended period, patients may even show symptoms similar to limbal stem cell deficiency. Understanding how glaucoma medications affect the function of corneal limbal stem cells is a critical clinical issue.
Objectives To evaluate the effect of glaucoma and anti-glaucoma agents on corneal epithelial and limbal epithelial thickness as a surrogate of limbal stem cell function, and to understand the association between tear fluid proteome and limbal function in glaucoma patients.
Methods We planned to include 90 subjects with glaucoma, and analyze the absolute thickness and variation of corneal epithelium and limbal epithelium. Tear fluid samples will be collected and proteomic analysis will be performed to elucidate the association between protein.
Anticipated Results To elucidate the impact of different types and cumulative doses of glaucoma medications on the thickness of the corneal epithelium and limbal epithelium, and to understand the relationship between limbal function and tear proteomics in glaucoma patients. The expected results may help develop early detection methods for changes in corneal and limbal epithelial function and provide valuable insights for future research on drug design and the protection of limbal stem cells.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy control | – | –Healthy control, without diagnosis of glaucoma. |
| Glaucoma, newly diagnosed | – | –Glaucoma patients who received topical antiglaucoma medications for less than 3 months. |
| Glaucoma, long-term medication use | – | –Glaucoma patients, received topical antiglaucoma medications for 1 year or longer. |
| Glaucoma, unilateral | – | –Patients with unilateral glaucoma or ocular hypertension and received treatment only in the diseased eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Glaucoma patients in outpatient clinic setting.
Key inclusion criteria (3 listed)
- Age ≥ 18 years. ii. Healthy Control Group: No diagnosis of glaucoma or ocular hypertension. iii. Glaucoma, Newly Diagnosed Group: Diagnosed with angle-closure glaucoma, open-angle glaucoma, or ocular hypertension; antiglaucoma medication usage for less than 3 months.
- Glaucoma, Long-term Medication Group: Diagnosed with angle-closure glaucoma, open-angle glaucoma, or ocular hypertension; continuous use of intraocular pressure-lowering medications for more than 1 year.
- Glaucoma, Unilateral Group: Diagnosed with unilateral glaucoma or ocular hypertension; only one eye receiving intraocular pressure-lowering treatment.
Key exclusion criteria (3 listed)
- History of severe ocular trauma, chemical burns, corneal ulcers, Stevens-Johnson syndrome with ocular involvement, or ocular graft-versus-host disease.
- History of corneal surgery, conjunctival surgery, trabeculectomy, or glaucoma drainage device implantation.
- Presence of ocular surface irregularity or limbal dysfunction due to conditions other than glaucoma or dry eye disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Limbal epithelial thickness
Time frame: Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)
Limbal epithelial thickness obtained from AS-OCT
2 secondary outcomes
Corneal central epithelial thickness
Time frame: Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)
Proteomic findings of tear samples
Time frame: Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)
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 13 Aug 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.
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 Glaucoma and Ocular Hypertension, run by National Taiwan University Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 13 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?
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 Wei-Lun Huang, MD (886-3-6677600 ext. 532267, weilunhuang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limbal epithelial thickness (time frame: Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)). 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 13 Aug 2025.