Dry Eye SyndromeNCT02774707
Comparing the Quality of Topical Autologous Serum in Different Etiologies of Dry Eye Syndrome
An observational study of Dry Eye Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Human autologous serum is commonly used in the treatment of dry eye disease. However, different patients may have different effect with autologous serum treatment. We would like to find if different autologous serum had different component of cytokines in different etiologies of dry eye. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Jan 2017
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Patients who need autologous human serum as treatment of dry eye disease 2. Healthy volunteers
Who may be able to join
- Healthy volunteer control without ophthalmic history
- Patients with Primary Sjogren's syndrome: according to the classification of American European Consensus Group of rheumatologist and Ophthalmologists,
- Patient with Secondary Sjogren's syndrome: Sjogren's syndrome associated with systemic lupus erythematosus, systemic sclerosis (scleroderma), rheumatoid arthritis, mixed connective tissue disease, inflammatory muscle disease, autoimmune liver disease, and autoimmune thyroid disease
- Ocular graft versus host disease
- Volunteers with dry eye symptoms but not diagnosed with primary Sjogren's syndrome, secondary Sjogren's syndrome and ocular graft versus host disease
Who cannot join
- Patients who decline to receive the venipuncture for blood sampling.
- Patients younger than 20 years old or older than 80 years old.
Trial locations and contacts
1 site in 1 country.
About this study
Human autologous serum is commonly used in the treatment of dry eye disease. However, different patients may have different effect with autologous serum treatment. We would like to find if different autologous serum had different component of cytokines in different etiologies of dry eye.
Read the detailed description
Dry eye is an important issue in the filed of ophthalmology and has great influence on the quality of life in many patients. Traditional treatment was mainly focused on artificial tear supplement. Inflammatory factors are identified in the recent days and are thought to play an important role in the etiology of dry eye. Anti-inflammatory agent like topical immunosuppressant has become another choice in the treatment of dry eye.
Conventional artificial tear has similar biochemical features and osmolarity with natural tear but lacks the anti-inflammatory cytokines. Therefore, autologous serum has been applied as a substitute of natural tear because it has more anti-inflammatory cytokines. Clinical trials have shown that autologous serum drops improve ocular irritation symptoms, and conjunctival and corneal dye staining in dry eye.
However, in the manufacture of autologous serum, it is hard to standardize every step and control quality. What's more, the patient may have different etiology of dry eye, including primary Sjogren's syndrome, secondary Sjogren's syndrome, other autoimmune disease, or ocular graft versus host disease. The etiology of dry eye may have different response to autologous serum. However, we don't know if the autologous serum from different patients' have different components and the different components of cytokines may have different treatment efficacy. This is what we want to know in this study.
Since human autologous serum is needed for cytokine analysis, we proposed this project to collect human serum from volunteers。
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry eye
- Medical subject headings
- Dry Eye Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidermal growth factor concentration in human autologous serum from different etiologies of dry eye
We would measure Epidermal growth factor concentration (ng/ml) by ELISA according to the manufactures instruction.
We plan to collect 40 patients from different groups.
Measured: 1 year
Transforming growth factor beta (ng/ml) concentration in human autologous serum from different etiologies of dry eye
We would measure Transforming growth factor beta (ng/ml) by ELISA according to the manufactures instruction.
We plan to collect 40 patients from different groups.
Measured: 1 year
Fibronectin (ug/ml) concentration in human autologous serum from different etiologies of dry eye
We would measureFibronectin (ug/ml) concentration by ELISA according to the manufactures instruction.
We plan to collect 40 patients from different groups.
Measured: 1 year
Hyaluronic acid (ug/ml) concentration in human autologous serum from different etiologies of dry eye
We would measure Hyaluronic acid (ug/ml) concentration by ELISA according to the manufactures instruction.
We plan to collect 40 patients from different groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
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 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
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Chen, Principal investigator, ational Taiwan University Hospital, Ophthalmology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774707
- Sponsor's protocol ID
- 201511091RINB
- Status last verified
- Dec 2016
- First submitted
- 10 Jan 2016
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Quality of Topical Autologous Serum in Different Etiologies of Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT02774707
- Acronym / sponsor ID
- 201511091RINB
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry eye
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 17 May 2016 (estimated)
- 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.
Human autologous serum is commonly used in the treatment of dry eye disease. However, different patients may have different effect with autologous serum treatment. We would like to find if different autologous serum had different component of cytokines in different etiologies of dry eye.
Detailed description
Dry eye is an important issue in the filed of ophthalmology and has great influence on the quality of life in many patients. Traditional treatment was mainly focused on artificial tear supplement. Inflammatory factors are identified in the recent days and are thought to play an important role in the etiology of dry eye. Anti-inflammatory agent like topical immunosuppressant has become another choice in the treatment of dry eye.
Conventional artificial tear has similar biochemical features and osmolarity with natural tear but lacks the anti-inflammatory cytokines. Therefore, autologous serum has been applied as a substitute of natural tear because it has more anti-inflammatory cytokines. Clinical trials have shown that autologous serum drops improve ocular irritation symptoms, and conjunctival and corneal dye staining in dry eye.
However, in the manufacture of autologous serum, it is hard to standardize every step and control quality. What's more, the patient may have different etiology of dry eye, including primary Sjogren's syndrome, secondary Sjogren's syndrome, other autoimmune disease, or ocular graft versus host disease. The etiology of dry eye may have different response to autologous serum. However, we don't know if the autologous serum from different patients' have different components and the different components of cytokines may have different treatment efficacy. This is what we want to know in this study.
Since human autologous serum is needed for cytokine analysis, we proposed this project to collect human serum from volunteers。
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients who need autologous human serum as treatment of dry eye disease 2. Healthy volunteers
Key inclusion criteria (5 listed)
- Healthy volunteer control without ophthalmic history
- Patients with Primary Sjogren's syndrome: according to the classification of American European Consensus Group of rheumatologist and Ophthalmologists,
- Patient with Secondary Sjogren's syndrome: Sjogren's syndrome associated with systemic lupus erythematosus, systemic sclerosis (scleroderma), rheumatoid arthritis, mixed connective tissue disease, inflammatory muscle disease, autoimmune liver disease, and autoimmune thyroid disease
- Ocular graft versus host disease
- Volunteers with dry eye symptoms but not diagnosed with primary Sjogren's syndrome, secondary Sjogren's syndrome and ocular graft versus host disease
Key exclusion criteria (2 listed)
- Patients who decline to receive the venipuncture for blood sampling.
- Patients younger than 20 years old or older than 80 years old.
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
Epidermal growth factor concentration in human autologous serum from different etiologies of dry eye
Time frame: 1 year
We would measure Epidermal growth factor concentration (ng/ml) by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.
Transforming growth factor beta (ng/ml) concentration in human autologous serum from different etiologies of dry eye
Time frame: 1 year
We would measure Transforming growth factor beta (ng/ml) by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.
Fibronectin (ug/ml) concentration in human autologous serum from different etiologies of dry eye
Time frame: 1 year
We would measureFibronectin (ug/ml) concentration by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.
Hyaluronic acid (ug/ml) concentration in human autologous serum from different etiologies of dry eye
Time frame: 1 year
We would measure Hyaluronic acid (ug/ml) concentration by ELISA according to the manufactures instruction. We plan to collect 40 patients from different groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
Wei-Li Chen principal investigator
ational Taiwan University Hospital, Ophthalmology Department
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, 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 5 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: status not confirmed, as of the sponsor's last update on 8 Dec 2016. 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?
Results are not available in the source record.
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?
Epidermal growth factor concentration in human autologous serum from different etiologies of dry eye (time frame: 1 year). 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 8 Dec 2016.