Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye (NCT06364657) | Clinical Trial Compass
TerminatedNot Applicable
Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye
Stopped: The study was prematurely closed to enrollment due to the principal investigator's departure from the institution (Johns Hopkins University).
United States13 participantsStarted 2024-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 epithe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.