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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06364657
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Johns Hopkins University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Esen K Akpek, MD
Principal Investigator Affiliation Johns Hopkins Hospital Wilmer Eye Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Sjogren's Syndrome, Dry Eye, Neurotrophic Keratitis
Arms & Interventions

Arms

: 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.

: 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

: Control

Age-matched healthy controls with no known history of ocular surface diseases or dry eye or any underlying autoimmune disease

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baltimore, Maryland

Status

Address

Johns Hopkins Hospital Wilmer Eye Institute

Baltimore, Maryland, 21287

Site Contact

Esen K Akpek, MD

[email protected]

410-955-5490

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