Dry Eye SyndromeNCT03576300
Comparison of Ocular Surface Features in Patients With Diabetes and Dry Eye Syndrome
An observational study of Dry Eye Syndrome and Diabetes Mellitus Type 2, run by Peking University Third Hospital at 1 site in China.
Trial summary
The study aims to compare the differences of ocular surface features in controls and patients with diabetes and dry eye syndrome, to thoroughly evaluate the ocular surface health of diabetics, and to find out the relationship between dry eye syndrome and diabetes Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome, Diabetes Mellitus Type 2
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 1 Aug 2018
- Phase
- Observational
- 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 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Asian
Who may be able to join
- dry eye diagnosis according to Expert's Consensus About Clinical Diagnosis and Treatment（Corneal Disease Group of Ophthalmological Society, Chinese Medical Association）: ①OSDI≥13，②positive dry eye soigns(ST≤10mm/5min；BUT≤10s；CFS>0)
- type 2 diabetes diagnosis according to American Diabetes Association：Standards of Medical Care in Diabetes -2017(ADA, American Diabetes Association)
- Willing to sign the consent form.
Who cannot join
- Having known Eye infection, allergy, malformation, abnormal eye movement
- Exclusion of eye injury, any kind of eye surgery
- Exclusion of other disease may cause neuropathy or influence tear producing
- Using systematic or local antibiotics that may influence tear producing
- Elimianation Criteria
- poor compliance
- voluntary withdrawal
- any other kind of situation that researchers consider not suitable for further study.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
The study aims to compare the differences of ocular surface features in controls and patients with diabetes and dry eye syndrome, to thoroughly evaluate the ocular surface health of diabetics, and to find out the relationship between dry eye syndrome and diabetes
Read the detailed description
In this study, we perform a completely comparison of ocular surface characteristic including the Ocular Surface Disease Index (OSDI) questionnaire,tearfilm break up time(BUT),corneal fluorescein scores(CFS),Shirmer test,corneal sensitivity)among diabetic patients with DE, diabetic patients without DE, non-diabetic patients with DE and normal subjects and analysis of EGF, IL-17A, IL-1β, IL-8 and TNF-α in tears and their clinical correlations are also performed to investigate potential biomarkers for diagnosis of diabetic with DE.
- Conditions
- Dry Eye Syndrome, Diabetes Mellitus Type 2
- Keywords
- ocular surface
- Medical subject headings
- Dry Eye Syndromes, Diabetes Mellitus, Type 2
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 |
|---|---|---|
| control | subjects without dry eye and diabetes | |
| patients with diabetes and dry eye | diabetic patients with dry eye | |
| diabetics without dry eye syndrome | diabetic patients without dry eye | |
| dry eye syndrome patients without diabetes | non-diabetic patients with dry eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear cytokines levels
Comparision the tear cytokines （EGF, IL-17A, IL-1β, IL-8 and TNF-α）levels in different groups using using a Milliplex Map Kit (Human Th17 Magnetic Bead Panel, Millipore, Billerica, MA).
Measured: through study completion,an average of two weeks
Secondary outcomes (1)
Clinical correlations of the tear cytokines
Analysis of tear cytokines and clinical correlations by Spearman correlation coefficient
Measured: through study completion,an average of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start1 Feb 2018
- Primary completion1 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Qi, Peking University Third Hospital
- Investigators
- Hong Qi, MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576300
- Sponsor's protocol ID
- IRB00006761-M2017354
- Status last verified
- May 2022
- First submitted
- 11 Jun 2018
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ocular Surface Features in Patients With Diabetes and Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT03576300
- Acronym / sponsor ID
- IRB00006761-M2017354
- Conditions
- Dry Eye Syndrome, Diabetes Mellitus Type 2
- Keywords
- ocular surface
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 3 Jul 2018 (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.
The study aims to compare the differences of ocular surface features in controls and patients with diabetes and dry eye syndrome, to thoroughly evaluate the ocular surface health of diabetics, and to find out the relationship between dry eye syndrome and diabetes
Detailed description
In this study, we perform a completely comparison of ocular surface characteristic including the Ocular Surface Disease Index (OSDI) questionnaire,tearfilm break up time(BUT),corneal fluorescein scores(CFS),Shirmer test,corneal sensitivity)among diabetic patients with DE, diabetic patients without DE, non-diabetic patients with DE and normal subjects and analysis of EGF, IL-17A, IL-1β, IL-8 and TNF-α in tears and their clinical correlations are also performed to investigate potential biomarkers for diagnosis of diabetic with DE.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | – | –subjects without dry eye and diabetes |
| patients with diabetes and dry eye | – | –diabetic patients with dry eye |
| diabetics without dry eye syndrome | – | –diabetic patients without dry eye |
| dry eye syndrome patients without diabetes | – | –non-diabetic patients with dry eye |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Asian
Key inclusion criteria (3 listed)
- dry eye diagnosis according to Expert's Consensus About Clinical Diagnosis and Treatment（Corneal Disease Group of Ophthalmological Society, Chinese Medical Association）: ①OSDI≥13，②positive dry eye soigns(ST≤10mm/5min；BUT≤10s；CFS>0)
- type 2 diabetes diagnosis according to American Diabetes Association：Standards of Medical Care in Diabetes -2017(ADA, American Diabetes Association)
- Willing to sign the consent form.
Key exclusion criteria (8 listed)
- Having known Eye infection, allergy, malformation, abnormal eye movement
- Exclusion of eye injury, any kind of eye surgery
- Exclusion of other disease may cause neuropathy or influence tear producing
- Using systematic or local antibiotics that may influence tear producing
- Elimianation Criteria
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
Tear cytokines levels
Time frame: through study completion,an average of two weeks
Comparision the tear cytokines （EGF, IL-17A, IL-1β, IL-8 and TNF-α）levels in different groups using using a Milliplex Map Kit (Human Th17 Magnetic Bead Panel, Millipore, Billerica, MA).
1 secondary outcome
Clinical correlations of the tear cytokines
Time frame: through study completion,an average of two weeks
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 3 May 2022.
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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.
Hong Qi, MD study director
Peking University Third Hospital
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 Syndrome and Diabetes Mellitus Type 2, run by Peking University Third 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 3 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: finished, as of the sponsor's last update on 3 May 2022. 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?
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?
Tear cytokines levels (time frame: through study completion,an average of two weeks). 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 3 May 2022.