A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment
A Longitudinal, Open-label, Multi-center Study to Explore the Relationship Between Signs, Symptoms, Molecular and Imaging Biomarkers in Participants With Dry Eye Disease Following Anti-inflammatory Treatment
Hoffmann-La Roche
350 participants
Jul 9, 2025
INTERVENTIONAL
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).
Eligibility
Inclusion Criteria5
- 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)
- \- The participant does not have overt clinical signs of DED in either eye
Exclusion Criteria9
- 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 or systemic disease
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants will receive Vevye® (0.1% cyclosporine ophthalmic solution) as per the schedule described in the treatment arm.
Participants will receive Xiidra® (5% lifitegrast ophthalmic solution) as per the schedule described in the treatment arm.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07025811