Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye (IIR)

January 13, 2025 updated by: Johns Hopkins University

Role of Neurotrophic Keratitis Versus Severity of Tear Film and Ocular Surface Parameters in Determining the Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye

In this study the investigators plan to enroll three groups of patients: non-Sjogren's dry eye, Sjogren's dry eye and controls. The study has the following primary goals:

  1. To determine whether dry eye is associated with reduced corneal sensation
  2. To determine whether reduced corneal sensation is due to the severity of the dry eye, the type of dry eye (primarily aqueous deficient versus primarily evaporative) or entirely related to the presence of Sjogren's
  3. To determine whether corneal sensation is associated with ocular or systemic pain symptoms Additionally, the study aims to compare the novel corneal esthesiometer measurements to confocal biomicroscopy findings in determining neurotrophic keratitis (NK) and assess correlations between corneal sensation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Richard C Medina, BA
  • Phone Number: 626-343-3967
  • Email: rmedin19@jh.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital Wilmer Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults aged 18 years or older, with and without Sjogren's-related dry eye, and no previous diagnosis of dry eye or other ocular surface disease.

Description

Inclusion Criteria:

  • Male or female aged 18 or older
  • Capacity to give informed consent
  • Self-reported literacy
  • Best corrected visual acuity at distance 20/40 in each eye

  • Signed Institutional Review Board (IRB)-approved consent agreeing to the terms of the study For Sjogren's-related dry eye, the below inclusion criteria will be required

    • a previous diagnosis of dry eye made by an eye care specialist
    • a previous diagnosis of Sjogren's made according to the 2016 revised Sjogren's classification criteria

Exclusion Criteria:

  • ● Age less than 18 years

    • Physical or mental issues, illiteracy, or language problems that might possibly interfere with reading ability or other condition that would preclude successful participation in this study
    • Contact lens wear within 10 days of enrollment
    • Any intraocular surgery (including cataract surgery) within the last 3 months
    • Any minor ocular surgery including tear duct cauterization or plugs within the last 30 days
    • Any history of corneal surgery (including LASIK/PRK) or cosmetic lid surgery in the past 12 months
    • Any history of glaucoma surgery (e.g., trabeculectomy or a tube shunt)
    • Best corrected vision worse than 20/40
    • Known history of severe ocular surface disease that might cause corneal haze and interfere with corneal staining score including but not limited to graft-versus-host disease, mucous membrane pemphigoid, atopic keratoconjunctivitis
    • Presence of keratoconus
    • Concurrent epithelial corneal disease or dystrophy (e.g., anterior basement membrane disease, pterygium, or scarring) that might affect the corneal staining score
    • Previous use of OXERVATE® for neurotrophic keratitis
    • Neurotrophic keratoconjunctivitis or corneal/conjunctival scarring (history of herpes simplex virus or varicella zoster virus keratitis)
    • Any blepharitis eyelid procedures such as Intense Pulsed Light (IPL), low level light treatment therapy, LipiFlow®, or nasolacrimal duct probing in the last 30 days prior to the study visit
    • Any acupuncture or physical therapy on the face or head within the past 3 months
    • Current smoker (within the past year)
    • Pregnant or nursing
    • Artificial tear use within 2 hours of study visit
    • Topical ophthalmic non-steroidal anti-inflammatory drug use 24 hours before the study visit
    • History of taking or current use of topical glaucoma drops or neurostimulation drugs or devices for treating dry eye
    • History or current intravitreal injections for macular degeneration
    • History of continuous positive airway pressure usage in the past 3 months
    • Any concurrent medical condition that in the judgment of the PI might interfere with the conduct of the study, confound the interpretation of the study results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sjogren's related dry-eye
Patients over the age of 18 years with known dry eye with underlying Sjogren's syndrome. Includes a previous diagnosis of dry eye made by an eye care specialist and a previous diagnosis of Sjogren's made according to the 2016 revised Sjogren's classification criteria.
Diagnostic test: Eye Exam
  • Symptom Questionnaires (OSDI, eye dryness VAS, visual fatigue VAS, eye discomfort VAS)
  • Pain scale questionnaire [Wong-Baker Faces Pain Rating Scale and Ocular Pain Assessment Survey
  • Best spectacle-corrected visual acuity (BSCVA) as measured by Snellen chart followed by Mars contrast sensitivity test.
  • Corneal esthesiometer for measurement of corneal sensation
  • Schirmer's without topical anesthesia
  • Corneal epithelial thickness sand endothelial cell count using Anterior Segment Optical Coherence Tomography (AS-OCT)
  • Staining for dry eye:
  • Tear film break-up time (BUT) using fluorescein.
  • Fluorescein staining (National Eye Institute (NEI) and Ocular staining score (OSS))
  • Lissamine green staining (OSS and Oxford)
  • Non-contact confocal biomicroscopy for morphology of the ocular surface
non-Sjogren's related dry-eye
Patients over the age of 18 years with known dry eye without underlying Sjogren's syndrome. Includes a previous diagnosis of dry eye made by an eye care specialist and a previous diagnosis of Sjogren's according to the 2016 revised Sjogren's classification criteria was definitively excluded
Diagnostic test: Eye Exam
  • Symptom Questionnaires (OSDI, eye dryness VAS, visual fatigue VAS, eye discomfort VAS)
  • Pain scale questionnaire [Wong-Baker Faces Pain Rating Scale and Ocular Pain Assessment Survey
  • Best spectacle-corrected visual acuity (BSCVA) as measured by Snellen chart followed by Mars contrast sensitivity test.
  • Corneal esthesiometer for measurement of corneal sensation
  • Schirmer's without topical anesthesia
  • Corneal epithelial thickness sand endothelial cell count using Anterior Segment Optical Coherence Tomography (AS-OCT)
  • Staining for dry eye:
  • Tear film break-up time (BUT) using fluorescein.
  • Fluorescein staining (National Eye Institute (NEI) and Ocular staining score (OSS))
  • Lissamine green staining (OSS and Oxford)
  • Non-contact confocal biomicroscopy for morphology of the ocular surface
Control
Age-matched healthy controls with no known history of ocular surface diseases or dry eye or any underlying autoimmune disease
Diagnostic test: Eye Exam
  • Symptom Questionnaires (OSDI, eye dryness VAS, visual fatigue VAS, eye discomfort VAS)
  • Pain scale questionnaire [Wong-Baker Faces Pain Rating Scale and Ocular Pain Assessment Survey
  • Best spectacle-corrected visual acuity (BSCVA) as measured by Snellen chart followed by Mars contrast sensitivity test.
  • Corneal esthesiometer for measurement of corneal sensation
  • Schirmer's without topical anesthesia
  • Corneal epithelial thickness sand endothelial cell count using Anterior Segment Optical Coherence Tomography (AS-OCT)
  • Staining for dry eye:
  • Tear film break-up time (BUT) using fluorescein.
  • Fluorescein staining (National Eye Institute (NEI) and Ocular staining score (OSS))
  • Lissamine green staining (OSS and Oxford)
  • Non-contact confocal biomicroscopy for morphology of the ocular surface

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Corneal Epithelium health
Time Frame: 1 Day
Measuring epithelial staining score and epithelial thickness map using anterior segment Optical coherence tomography (OCT)
1 Day
Corneal Nerve health
Time Frame: 1 Day
Corneal sensation using non-contact esthesiometer and corneal nerve density and morphology using non-contact confocal biomicroscopy
1 Day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Correlations Between Corneal Staining Score
Time Frame: 1 Day
Correlations between corneal staining score with visual parameters, epithelial thickness map, corneal nerve density and morphology, and corneal sensation
1 Day
Correlations Between Patient Symptoms
Time Frame: 1 Day
Correlations between the patient symptoms and above corneal findings using Ocular Surface Disease Index (OSDI), Visual Acuity Scale (VAS), and pain scale questionnaire
1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dompe U.S. Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Esen K Akpek, MD, Johns Hopkins Hospital Wilmer Eye Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00439625

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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