NCT02712762

Brief Summary

This study aims to profile the ocular surface inflammation of chronic Graft-Versus-Host Disease patients by investigating conjunctival cells, and clinical imaging for conjunctival redness and tear stability. Hence, the investigators expect to find an increased in inflammatory cell population in GVHD conjunctival samples.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

March 8, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

4.4 years

First QC Date

March 8, 2016

Last Update Submit

April 15, 2024

Conditions

Dry EyeGVHD

Keywords

immunological profiles

Outcome Measures

Primary Outcomes (1)

  • Dry Eye Symptoms (SPEED Questionnaire)

    Baseline

Secondary Outcomes (6)

  • Non-invasive Tear Break-up Time (NIKBUT)

    Baseline

  • Imaging of Conjunctival Redness

    Baseline

  • Tear production with Schirmers I test

    Baseline

  • Measuring tear biomarker

    Baseline

  • Conjunctival Immune Cell Profile

    Baseline

  • +1 more secondary outcomes

Interventions

Cross-sectional studyOTHER

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a cross-sectional study involving 30 consecutive suitable GVHD patients. Suitable patients will be identified by haematologists from the SGH transplantation Centre (Block 7, level 1). Study duration: One visit Recruitment duration: 1 Year

You may qualify if:

  • \. Clinically diagnosed with chronic Graft Versus Host Disease (GVHD).

You may not qualify if:

  • No ocular surgery within the last 3 months and LASIK within 1 year.
  • Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos.
  • Any other specified reason as determined by clinical investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cynthia Boo

Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 18, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

April 17, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)