A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti… (NCT07025811) | Clinical Trial Compass
Active — Not RecruitingPhase 4
A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment
United States378 participantsStarted 2025-07-09
Plain-language summary
This study aims to evaluate the performance of biomarkers and their responsiveness to standard-of-care treatments (Vevye® or Xiidra®), in participants with dry eye disease (DED) compared to healthy volunteers (control participants).
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:
A. Inclusion Criteria for Participants with DED:
* The participant reported dry eye-related ocular symptoms for at least 6 months before the screening visit
* The participant must have either used lubricant eye drops regularly OR had the desire to use lubricant eye drops in the past 3 months
* Participant must be classified as having moderate/severe DED
* The participant is deemed by the physician to require a prescription medication for DED (e.g., cyclosporin A or lifitegrast)
B. Inclusion Criteria for Healthy Volunteers:
\- The participant does not have overt clinical signs of DED in either eye
Exclusion Criteria:
* Intraocular pressure (IOP) \>21.00 millimeters of mercury (mmHg) in either eye
* Acute allergic conjunctivitis in either eye within 3 months prior to screening
* Use of contact lenses within 30 days prior to screening
* Punctal plugs within 3 months prior to screening or any history of punctal cauterization or occlusion by an approach different from punctal plugs
* Use of ocular anti-inflammatory agents or ocular immunosuppressive agents within 3 months prior to screening
* Any intraocular injections (e.g., intravitreal \[IVT\] anti-vascular endothelial growth factor \[VEGF\]) within 3 months prior to screening, or such injections planned for within the study period
* Any intraocular immunosuppressive implants within 12 months prior to screening
* Any history of isotretinoin use within 12 months prior to screening
* Uncontrolled ocular …
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.
What they're measuring
1
Change From Baseline in Corneal Staining as Measured by Sodium Fluorescein