Sjogren's SyndromeNCT03203382
Corneal Nerve Structure in Sjogren's
An observational study of Sjogren's Syndrome and Vitamin D Deficiency, run by University of Pennsylvania at 1 site in United States.
Trial summary
Patients who are suspected of or diagnosed with Sjogren's disease will be evaluated for ocular symptoms and corneal nerve morphology. We are specifically interested in the relationship between Vitamin D level and aberrations in the morphology of the corneal nerves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome, Vitamin D Deficiency
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suspected or confirmed Sjogren's patients
Who may be able to join
- Suspected or confirmed Sjogren's syndrome
- 18+ years of age
Who cannot join
- Any condition that in the opinion of the investigator may confound study results or cause concerns for safety
Trial locations and contacts
1 site in 1 country.
United States1 site
Scheie Eye Institute of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Patients who are suspected of or diagnosed with Sjogren's disease will be evaluated for ocular symptoms and corneal nerve morphology. We are specifically interested in the relationship between Vitamin D level and aberrations in the morphology of the corneal nerves.
Read the detailed description
Patients with either suspected or confirmed diagnosis of Sjogren's disease will be recruited to participate. Participation will involve the completion of a brief survey (the OSDI), corneal evaluation with an aesthesiometer, corneal staining with fluorescein and lissamine green, and finally measurement of tear-film breakup time. In addition, participants will have their corneal nerve morphology evaluated with the Heidelberg confocal microscope and finally they will have a blood draw performed to assess vitamin D level.
- Conditions
- Sjogren's Syndrome, Vitamin D Deficiency
- Medical subject headings
- Sjogren's Syndrome, Vitamin D Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Nerve Morphology
Heidelberg Retina Tomograph with the Rostock Cornea Module
Measured: one time exam
Vitamin D Level
serum
Measured: one time exam at baseline, day 1
Secondary outcomes (1)
vital dye staining
corneal staining
Measured: one time exam at baseline, day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study startSep 2015
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giacomina Massaro-Giordano, Principal investigator, Scheie Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03203382
- Sponsor's protocol ID
- 823009
- Status last verified
- Aug 2021
- First submitted
- 4 Jan 2017
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Nerve Structure in Sjogren's
- ClinicalTrials.gov ID
- NCT03203382
- Acronym / sponsor ID
- 823009
- Conditions
- Sjogren's Syndrome, Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Jun 2017 (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.
Patients who are suspected of or diagnosed with Sjogren's disease will be evaluated for ocular symptoms and corneal nerve morphology. We are specifically interested in the relationship between Vitamin D level and aberrations in the morphology of the corneal nerves.
Detailed description
Patients with either suspected or confirmed diagnosis of Sjogren's disease will be recruited to participate. Participation will involve the completion of a brief survey (the OSDI), corneal evaluation with an aesthesiometer, corneal staining with fluorescein and lissamine green, and finally measurement of tear-film breakup time. In addition, participants will have their corneal nerve morphology evaluated with the Heidelberg confocal microscope and finally they will have a blood draw performed to assess vitamin D level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected or confirmed Sjogren's patients
Key inclusion criteria (2 listed)
- Suspected or confirmed Sjogren's syndrome
- 18+ years of age
Key exclusion criteria (1 listed)
- Any condition that in the opinion of the investigator may confound study results or cause concerns for safety
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
Corneal Nerve Morphology
Time frame: one time exam
Heidelberg Retina Tomograph with the Rostock Cornea Module
Vitamin D Level
Time frame: one time exam at baseline, day 1
serum
1 secondary outcome
vital dye staining
Time frame: one time exam at baseline, day 1
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 4 Aug 2021.
Related trials for Sjogren's Syndrome
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease
Sjögren's Disease
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
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.
Giacomina Massaro-Giordano principal investigator
Scheie Eye Institute
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 Sjogren's Syndrome and Vitamin D Deficiency, run by University of Pennsylvania at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 4 Aug 2021. 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 United States. 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?
Corneal Nerve Morphology (time frame: one time exam). The study lists 2 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 4 Aug 2021.