Dry Eye SyndromeNCT00991679
CXCL9, CXCL10, CXCL11, and CXCR3 in Dry Eye Syndrome
An observational study of Dry Eye Syndrome, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is to investigate the expression of CXCL9, CXCL10, CXCL11, and CXCR3 in the tear film and ocular surface of patients with dry eye syndrome. Thirty-three patients with dry eye (16 Sjögren's syndrome and 17 non-Sjögren's syndrome patients) and 15 control subjects were recruited. Read more about this study
- Who is it for?
- Ages 24 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2008to Dec 2008
- 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 24 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- clinical diagnosis of dry eye syndrome
Who cannot join
- active ocular infection or inflammation not associated with dry eye
- drug toxicity
- contact lens wear
- ocular allergy
- ocular surgery within the last 3 months
- lid or lash abnormalities
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chonnam National University Hospital
Gwangju, Chonnam, 501-757
About this study
Official title: Expression of CXCL9, CXCL10, CXCL11, and CXCR3 in the Tear Film and Ocular Surface of Patients With Dry Eye Syndrome
The aim of this study is to investigate the expression of CXCL9, CXCL10, CXCL11, and CXCR3 in the tear film and ocular surface of patients with dry eye syndrome.
Thirty-three patients with dry eye (16 Sjögren's syndrome and 17 non-Sjögren's syndrome patients) and 15 control subjects were recruited. The concentrations of CXCL9, CXCL10, and CXCL11 in tears were measured using enzyme-linked immunosorbent assay. The correlation between chemokine levels and tear film and ocular surface parameters was analyzed. Expression of CXCL9, CXCL10, CXCL11, and CXCR3 in the conjunctiva was evaluated using immunohistochemistry. Flow cytometry was performed to count CXCR3+ cells and CXCR3+CD4+ cells in the conjunctiva.
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry eye syndrome, CXCL9 chemokine, CXCL10 chemokine, CXCL11 chemokine, CXCR3 receptor
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Normal control subjects | Normal control subjects who did not show the clinical symptom and findings of dry eye syndrome. | |
| dry eye patients | Patients with dry eye syndrome who had symptoms of dry eye for more than 3 months, low tear film break up time (BUT, ≤7 sec), low Schirmer test (<10 mm), low tear clearance rate (<8X), and positive fluorescein or rose bengal vital staining (≥3) and were not treated with anti-inflammatory agents such as topical cyclosporine or steroids were included in the study. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startFeb 2008
- Primary completionOct 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kyung-Chul Yoon, MD, PhD, Study director, Department of Ophthalmology, Chonnam National University Medical School and Hospital, Gwangju, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991679
- Sponsor's protocol ID
- I-2007-12-111
- Status last verified
- Oct 2009
- First submitted
- 7 Oct 2009
- Last updated
- 8 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yoon KC, De Paiva CS, Qi H, Chen Z, Farley WJ, Li DQ, Pflugfelder SC. Expression of Th-1 chemokines and chemokine receptors on the ocular surface of C57BL/6 mice: effects of desiccating stress. Invest Ophthalmol Vis Sci. 2007 Jun;48(6):2561-9. doi: 10.1167/iovs.07-0002.
PubMed 17525185Wallace GR, John Curnow S, Wloka K, Salmon M, Murray PI. The role of chemokines and their receptors in ocular disease. Prog Retin Eye Res. 2004 Jul;23(4):435-48. doi: 10.1016/j.preteyeres.2004.04.004.
PubMed 15219876Pflugfelder SC, Jones D, Ji Z, Afonso A, Monroy D. Altered cytokine balance in the tear fluid and conjunctiva of patients with Sjogren's syndrome keratoconjunctivitis sicca. Curr Eye Res. 1999 Sep;19(3):201-11. doi: 10.1076/ceyr.19.3.201.5309.
PubMed 10487957Yoon KC, Park CS, You IC, Choi HJ, Lee KH, Im SK, Park HY, Pflugfelder SC. Expression of CXCL9, -10, -11, and CXCR3 in the tear film and ocular surface of patients with dry eye syndrome. Invest Ophthalmol Vis Sci. 2010 Feb;51(2):643-50. doi: 10.1167/iovs.09-3425. Epub 2009 Oct 22.
PubMed 19850844
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of CXCL9, CXCL10, CXCL11, and CXCR3 in the Tear Film and Ocular Surface of Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT00991679
- Acronym / sponsor ID
- I-2007-12-111
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry eye syndrome, CXCL9 chemokine, CXCL10 chemokine, CXCL11 chemokine, CXCR3 receptor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Oct 2009 (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.
The aim of this study is to investigate the expression of CXCL9, CXCL10, CXCL11, and CXCR3 in the tear film and ocular surface of patients with dry eye syndrome.
Thirty-three patients with dry eye (16 Sjögren's syndrome and 17 non-Sjögren's syndrome patients) and 15 control subjects were recruited. The concentrations of CXCL9, CXCL10, and CXCL11 in tears were measured using enzyme-linked immunosorbent assay. The correlation between chemokine levels and tear film and ocular surface parameters was analyzed. Expression of CXCL9, CXCL10, CXCL11, and CXCR3 in the conjunctiva was evaluated using immunohistochemistry. Flow cytometry was performed to count CXCR3+ cells and CXCR3+CD4+ cells in the conjunctiva.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal control subjects | – | –Normal control subjects who did not show the clinical symptom and findings of dry eye syndrome. |
| dry eye patients | – | –Patients with dry eye syndrome who had symptoms of dry eye for more than 3 months, low tear film break up time (BUT, ≤7 sec), low Schirmer test (<10 mm), low tear clearance rate (<8X), and positive fluorescein or rose bengal vital staining (≥3) and were not treated with anti-inflammatory agents such as topical cyclosporine or steroids were included in the study. |
Who may qualify
- Ages
- 24 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- clinical diagnosis of dry eye syndrome
Key exclusion criteria (6 listed)
- active ocular infection or inflammation not associated with dry eye
- drug toxicity
- contact lens wear
- ocular allergy
- ocular surgery within the last 3 months
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
Not reported in the source record.
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 8 Oct 2009.
- Results publication: PubMed 17525185Yoon KC, De Paiva CS, Qi H, Chen Z, Farley WJ, Li DQ, Pflugfelder SC. Expression of Th-1 chemokines and chemokine receptors on the ocular surface of C57BL/6 mice: effects of desiccating stress. Invest Ophthalmol Vis Sci. 2007 Jun;48(6):2561-9. doi: 10.1167/iovs.07-0002.
- Results publication: PubMed 15219876Wallace GR, John Curnow S, Wloka K, Salmon M, Murray PI. The role of chemokines and their receptors in ocular disease. Prog Retin Eye Res. 2004 Jul;23(4):435-48. doi: 10.1016/j.preteyeres.2004.04.004.
- Results publication: PubMed 10487957Pflugfelder SC, Jones D, Ji Z, Afonso A, Monroy D. Altered cytokine balance in the tear fluid and conjunctiva of patients with Sjogren's syndrome keratoconjunctivitis sicca. Curr Eye Res. 1999 Sep;19(3):201-11. doi: 10.1076/ceyr.19.3.201.5309.
- Derived from this study: PubMed 19850844Yoon KC, Park CS, You IC, Choi HJ, Lee KH, Im SK, Park HY, Pflugfelder SC. Expression of CXCL9, -10, -11, and CXCR3 in the tear film and ocular surface of patients with dry eye syndrome. Invest Ophthalmol Vis Sci. 2010 Feb;51(2):643-50. doi: 10.1167/iovs.09-3425. Epub 2009 Oct 22.
Related trials for Dry Eye Syndrome
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
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.
Kyung-Chul Yoon, MD, PhD study director
Department of Ophthalmology, Chonnam National University Medical School and Hospital, Gwangju, South Korea
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 Chonnam National University Hospital at 1 site in South Korea.
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 6 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 8 Oct 2009. 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 South Korea. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00991679, which also lists 4 linked publications.
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 Oct 2009.