Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exploring Immune Cell Signatures in Autoimmunity and Dry Eye Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715323
Recruitment Status : Recruiting
First Posted : March 22, 2016
Last Update Posted : May 10, 2019
Sponsor:
Collaborators:
SingHealth Translational Immunology and Inflammation Centre
TTSH Eye Clinic
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre

Brief Summary:

Ocular surface disease, especially dry eye and scleritis, commonly affects patients with autoimmune diseases. Ocular surface immune cells are increased in autoimmune disease; however the full subset of immune cells activated is unknown. Recent experimental studies show that dendritic cells and T cells in the cornea are critically associated with corneal nerve innervation. Corneal confocal microscopy (CCM) allows rapid non-invasive in vivo imaging of dendritic cells and corneal nerves. The investigators propose to investigate how ocular surface health, conjunctival immune cells and corneal nerve/dendritic cell morphology interact in 3 rheumatological conditions: Sjogren's syndrome (SS), Rheumatoid arthritis (RA), Systemic lupus erythematosus (SLE).

The preliminary flow cytometric studies show that various immune cells (eg: T cells, B cells, and dendritic cells) can be quantified using minimally invasive impression membranes (Eyeprim). Clinically, the research team is experienced in measuring features of ocular surface inflammation (conjunctival redness, tear breakup times) with Oculus keratograph5M. The investigators also aim to harvest conjunctival immune cells using impression cytology and quantify specific cell types with flow cytometry. Corneal nerve morphology and dendritic cell density and distribution will be assessed using CCM; in collaboration with the group who have pioneered this technique.

The investigator anticipate that alterations in corneal nerve and dendritic cell parameters will correlate with immune activation/inflammation, deterioration of tear function and increased systemic severity of the rheumatological disease. In addition, the investigators hypothesize that the lower the corneal nerve density, the higher the number of corneal dendritic cells and conjunctival inflammatory cells. Studying these relationships may allow a better mechanistic understanding of local corneal and systemic immune activation and the development of a non-invasive ophthalmic surrogate marker of dendritic cell activation and nerve fibre loss to aid earlier diagnosis, risk stratification and the development of new therapies in autoimmune patients with severe dry eye.


Condition or disease Intervention/treatment
Autoimmunity Dry Eye Syndrome Other: Cross-sectional study

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exploring Immune Cell Signatures in Autoimmunity and Ocular Surface Stress
Actual Study Start Date : May 2016
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Dry Eye Symptoms (SPEED Questionnaire) [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Non-invasive Tear Break-up Time (NIKBUT) [ Time Frame: Day 0 ]
  2. Conjunctival Redness Grading with Oculus Keratograph 5M [ Time Frame: Day 0 ]
  3. Tear collection from Schirmers strip [ Time Frame: Day 0 ]
  4. To profile immune cells with EyePRIM membrane [ Time Frame: Day 0 ]
    Patients will be instilled with 1 drop of local anaesthetic. Conjunctival cells will be collected using EyePrim membrane by applying the membrane on the temporal and nasal conjunctival, the conjunctival cells will then be scrapped off the membrane using a 10ul micropipette tip into the 1.5ml of RPMI solution in a 2ml eppendorf tube. On the same day, FACs analysis will be done on the cells in the lab.

  5. Documenting Corneal Fluorescein Staining [ Time Frame: Day 0 ]
  6. Measuring cornea nerve density [ Time Frame: Day 0 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We will recruit patients with 3 specific rheumatological diagnoses and controls

  • SS (n=40), RA (n=40), SLE (n=40)
  • Healthy age/ethnicity/sex matched control subjects (n=40)

Total sample size: 160

Criteria

Inclusion criteria:

Recruitment inclusion criteria for Systemic diseases participants:

1. Clinically diagnosed with Primary Sjogren's Syndrome, Rheumatoid Arthritis or Systemic Lupus Erythematosus.

Recruitment inclusion criteria for controls:

  1. NO Dry eye or severe Meibomian Gland Disease
  2. NO current or recent (< 6 months) conjunctivitis, keratitis, uveitis or other inflammatory condition affecting eye
  3. NO recent ocular surgery or LASIK (< 6 months)
  4. Frequency of dry eye symptoms is < once/week (burning, tearing, itching, foreign body sensation, transient blurring improved by blinking)
  5. NO contact lens wear for the past 1 week
  6. NO systemic conditions of Diabetes Mellitus, Rheumatoid Arthritis, Systemic Lupus Erythematosus
  7. Bulbar redness is < 1.5 grading

Exclusion Criteria:

  1. Known history of thyroid disorders (diagnosed by physician)
  2. No ocular surgery within the last 3 months and LASIK within 1 year.
  3. Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos.
  4. Any other specified reason as determined by clinical investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715323


Locations
Layout table for location information
Singapore
Cynthia Boo Recruiting
Singapore, Singapore, 168751
Contact: Cynthia Boo, BSc    98206648    cynthia.boo.s.k@seri.com.sg   
Sponsors and Collaborators
Singapore National Eye Centre
SingHealth Translational Immunology and Inflammation Centre
TTSH Eye Clinic

Layout table for additonal information
Responsible Party: Louis Tong, Principal Investigator, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT02715323    
Other Study ID Numbers: R1295/101/2015 (SERI-STIIC-3)
2016/2048 ( Registry Identifier: SingHealth CIRB )
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Louis Tong, Singapore National Eye Centre:
dry eye
immunological profile
autoimmune
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Autoimmune Diseases
Syndrome
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Immune System Diseases