Dry EyeNCT06287879
Function and Morphological Characteristics of Meibomian Gland in Patients With Renal Anemia
A study testing Dry eye examination in people with Dry Eye and MGD-Meibomian Gland Dysfunction, run by Zhongnan Hospital at 1 site in China.
Trial summary
Renal anemia refers to anemia in which the absolute or relative production of erythropoietin (EPO) is insufficient due to various kidney diseases, and uremic toxins affect erythropoietin production and its lifespan. Common treatment drugs for renal anemia include erythropoietin EPO and Roxadustat (FG-4592). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dry Eye, MGD-Meibomian Gland Dysfunction
- What is being tested?
- Dry eye examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 30 Dec 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- long-term use of Roxadustat or erythropoietin for renal anemia
Who cannot join
- contact lens wearer, history of eye surgeries, systemic health conditions affecting ocular health and those who were unable to cooperate with examinations
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Min Ke, Doctor, +86-18672395959, keminyk@163.com
About this study
Renal anemia refers to anemia in which the absolute or relative production of erythropoietin (EPO) is insufficient due to various kidney diseases, and uremic toxins affect erythropoietin production and its lifespan. Common treatment drugs for renal anemia include erythropoietin EPO and Roxadustat (FG-4592).
Medical history information was collected from patients with renal anemia who visited the ophthalmology department with dry eye symptoms.
This study will help to determine the function and morphological characteristics of meibomian gland in patients with renal anemia
Read the detailed description
- Collect medical records of patients with renal anemia who visited the ophthalmology outpatient department of Zhongnan Hospital and hospitalized patients with renal anemia
- Patients were divided into Rosallistat group, and EPO group according to their drug use history.
- The dry eye analysis results of all patients were collected, and the lacrimal river height, tear film rupture time and meibomian gland grade were counted. The results of dry eye examination were analyzed statistically.
- Complete data collection, conduct statistical analysis, and evaluate the analysis results.
- Conditions
- Dry Eye, MGD-Meibomian Gland Dysfunction
- Being tested
- Dry eye examination
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry eye examinationDiagnostic test
- Lacrimal river height
- tear break-up time
- tear-film lipid layer thickness
- meibomian glands two-dimensional digital infrared images
| Study group | Role | What they receive |
|---|---|---|
| Roxadustat | Experimental | Subjects were treated with Roxadustat for renal anemia Receives: Diagnostic Test: Dry eye examination |
| EPO | Active comparator | Subjects were treated with EPO for renal anemia Receives: Diagnostic Test: Dry eye examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lacrimal river height
Measured by dry eye analyzer machine
Measured: Immediately and six months later
tear break-up time
Measured by dry eye analyzer machine
Measured: Immediately and six months later
tear-film lipid layer thickness
Measured by dry eye analyzer machine
Measured: Immediately and six months later
meibomian glands two-dimensional digital infrared images
Measured by dry eye analyzer
Measured: Immediately and six months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Apr 2023
- Primary completion20 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287879
- Sponsor's protocol ID
- 20231121
- Status last verified
- Nov 2023
- First submitted
- 1 Feb 2024
- Last updated
- 1 Mar 2024
- 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 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Function and Morphological Characteristics of Meibomian Gland in Patients With Renal Anemia
- ClinicalTrials.gov ID
- NCT06287879
- Acronym / sponsor ID
- 20231121
- Conditions
- Dry Eye, MGD-Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 1 Mar 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.
Renal anemia refers to anemia in which the absolute or relative production of erythropoietin (EPO) is insufficient due to various kidney diseases, and uremic toxins affect erythropoietin production and its lifespan. Common treatment drugs for renal anemia include erythropoietin EPO and Roxadustat (FG-4592).
Medical history information was collected from patients with renal anemia who visited the ophthalmology department with dry eye symptoms.
This study will help to determine the function and morphological characteristics of meibomian gland in patients with renal anemia
Detailed description
- Collect medical records of patients with renal anemia who visited the ophthalmology outpatient department of Zhongnan Hospital and hospitalized patients with renal anemia
- Patients were divided into Rosallistat group, and EPO group according to their drug use history.
- The dry eye analysis results of all patients were collected, and the lacrimal river height, tear film rupture time and meibomian gland grade were counted. The results of dry eye examination were analyzed statistically.
- Complete data collection, conduct statistical analysis, and evaluate the analysis results.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Roxadustat | Experimental | Diagnostic Test: Dry eye examinationSubjects were treated with Roxadustat for renal anemia |
| EPO | Active comparator | Diagnostic Test: Dry eye examinationSubjects were treated with EPO for renal anemia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- long-term use of Roxadustat or erythropoietin for renal anemia
Key exclusion criteria (1 listed)
- contact lens wearer, history of eye surgeries, systemic health conditions affecting ocular health and those who were unable to cooperate with examinations
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 |
|---|---|---|
| Dry eye examination1. Lacrimal river height 2. tear break-up time 3. tear-film lipid layer thickness 4. meibomian glands two-dimensional digital infrared images | Diagnostic test | EPO, Roxadustat |
Primary outcome
Lacrimal river height
Time frame: Immediately and six months later
Measured by dry eye analyzer machine
tear break-up time
Time frame: Immediately and six months later
Measured by dry eye analyzer machine
tear-film lipid layer thickness
Time frame: Immediately and six months later
Measured by dry eye analyzer machine
meibomian glands two-dimensional digital infrared images
Time frame: Immediately and six months later
Measured by dry eye analyzer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry eye examination in people with Dry Eye and MGD-Meibomian Gland Dysfunction, run by Zhongnan 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 1 Mar 2024. 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?
Results are not available in the source record.
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?
Lacrimal river height (time frame: Immediately and six months later). The study lists 4 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 1 Mar 2024.