Primary Sjogren's SyndromeNCT00920179
Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome
An observational study of Primary Sjogren's Syndrome, run by Keio University at 1 site in Japan.
Trial summary
Traditional methodological clinical and instrumental diagnostics of the lacrimal gland for the study of glandular architecture and functions are limited and include analysis of tear constituents, evaluation of apparent diffusion coefficients in magnetic resonance imaging and histopathological evaluation of lacrimal… Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Sjogren's Syndrome
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2007to Dec 2010
- 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: Patients with primary SS and healthy controls
Who may be able to join
- The Sjögren's syndrome diagnosis was made according to the revised American-European consensus criteria.
- Briefly, the patients had to have ocular and oral symptoms of dryness,
- clinically diagnosed dry eye and dry mouth disease,
- serum rheumatoid factor and antinuclear antibody levels ≥1:160,
- positive serology for anti SS-A or anti SS-B antibodies,
- labial salivary gland inflammatory infiltration focus score ≥2 and consents for lacrimal gland biopsy to be included into this study.
Who cannot join
- Patients with any history of ocular surgery including punctal occlusion,
- other ocular or systemic disease
- or a history of topical/ systemic drug use or contact lens wear or
- other systemic disorders that would cause dry eyes or that would alter the ocular surface.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Application of In Vivo Confocal Scanning Laser Microscopy in the Evaluation of the Secretory Glands in Patients With Sjögren's Syndrome
Traditional methodological clinical and instrumental diagnostics of the lacrimal gland for the study of glandular architecture and functions are limited and include analysis of tear constituents, evaluation of apparent diffusion coefficients in magnetic resonance imaging and histopathological evaluation of lacrimal gland biopsy specimens. Confocal microscopy is a new emerging technology which is useful as a supplementary diagnostic tool for in vivo assessment of anterior-segment disorders.The use of in vivo confocal microscopy in a comparative study of the microscopic morphology of the salivary/lacrimal glands have not been reported up to date. In this study, we employ laser scanning confocal microscopy to evaluate the morphological changes of the salivary/lacrimal glands in patients with primary Sjögren's syndrome and compare the results with those of healthy control subjects.
- Conditions
- Primary Sjogren's Syndrome
- Keywords
- dry eye, in vivo confocal microscopy, inflammation, acinar unit density, lacrimal gland
- Medical subject headings
- Dry Eye Syndromes, Inflammation
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 |
|---|---|---|
| Dry eye group | Dry eye patients with Primary Sjogren's syndrome | |
| Controls | Healthy subjects without dry eyes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory cell density
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startOct 2007
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjogren's 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keio University
- Sponsor type
- University, hospital or other
- Investigators
- Kazuo Tsubota, Professor, Study director, Keio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920179
- Sponsor's protocol ID
- 21071965
- Status last verified
- Jun 2009
- First submitted
- 12 Jun 2009
- Last updated
- 15 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of In Vivo Confocal Scanning Laser Microscopy in the Evaluation of the Secretory Glands in Patients With Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT00920179
- Acronym / sponsor ID
- 21071965
- Conditions
- Primary Sjogren's Syndrome
- Keywords
- dry eye, in vivo confocal microscopy, inflammation, acinar unit density, lacrimal gland
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Keio UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2010 (estimated)
- First posted
- 15 Jun 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.
Traditional methodological clinical and instrumental diagnostics of the lacrimal gland for the study of glandular architecture and functions are limited and include analysis of tear constituents, evaluation of apparent diffusion coefficients in magnetic resonance imaging and histopathological evaluation of lacrimal gland biopsy specimens. Confocal microscopy is a new emerging technology which is useful as a supplementary diagnostic tool for in vivo assessment of anterior-segment disorders.The use of in vivo confocal microscopy in a comparative study of the microscopic morphology of the salivary/lacrimal glands have not been reported up to date. In this study, we employ laser scanning confocal microscopy to evaluate the morphological changes of the salivary/lacrimal glands in patients with primary Sjögren's syndrome and compare the results with those of healthy control subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry eye group | – | –Dry eye patients with Primary Sjogren's syndrome |
| Controls | – | –Healthy subjects without dry eyes |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary SS and healthy controls
Key inclusion criteria (6 listed)
- The Sjögren's syndrome diagnosis was made according to the revised American-European consensus criteria.
- Briefly, the patients had to have ocular and oral symptoms of dryness,
- clinically diagnosed dry eye and dry mouth disease,
- serum rheumatoid factor and antinuclear antibody levels ≥1:160,
- positive serology for anti SS-A or anti SS-B antibodies,
Key exclusion criteria (4 listed)
- Patients with any history of ocular surgery including punctal occlusion,
- other ocular or systemic disease
- or a history of topical/ systemic drug use or contact lens wear or
- other systemic disorders that would cause dry eyes or that would alter the ocular surface.
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
Inflammatory cell density
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2009.
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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.
Kazuo Tsubota, Professor study director
Keio University
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 Primary Sjogren's Syndrome, run by Keio University at 1 site in Japan.
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 6 inclusion and 4 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 15 Jun 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 Japan. 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?
Inflammatory cell density (time frame: 1.5 years). 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 15 Jun 2009.