NCT03203382

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
Last Updated

August 4, 2021

Status Verified

August 1, 2021

Enrollment Period

1.6 years

First QC Date

January 4, 2017

Last Update Submit

August 3, 2021

Conditions

Sjogren's SyndromeVitamin D Deficiency

Outcome Measures

Primary Outcomes (2)

  • Corneal Nerve Morphology

    Heidelberg Retina Tomograph with the Rostock Cornea Module

    one time exam

  • Vitamin D Level

    serum

    one time exam at baseline, day 1

Secondary Outcomes (1)

  • vital dye staining

    one time exam at baseline, day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Suspected or confirmed Sjogren's patients

You may qualify if:

  • Suspected or confirmed Sjogren's syndrome
  • + years of age

You may not qualify if:

  • Any condition that in the opinion of the investigator may confound study results or cause concerns for safety

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scheie Eye Institute of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sjogren's SyndromeVitamin D Deficiency

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Giacomina Massaro-Giordano

    Scheie Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

June 29, 2017

Study Start

September 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

August 4, 2021

Record last verified: 2021-08

Locations

US(1)