A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment

Launched by HOFFMANN-LA ROCHE · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying dry eye disease, a condition where your eyes don’t produce enough tears or the right kind of tears, leading to discomfort and vision problems. The study aims to see how certain signs and substances in the eye (called biomarkers) respond to common anti-inflammatory treatments, like Vevye® or Xiidra®, in people with moderate to severe dry eye disease compared to people with healthy eyes.

If you have had dry eye symptoms for at least six months, have used or wanted to use lubricant eye drops recently, and your doctor thinks you need prescription medication for dry eye, you might be eligible to join. Healthy volunteers without signs of dry eye are also needed for comparison. Participants should not have certain eye conditions or treatments, such as high eye pressure or recent eye injections. While the study is not yet recruiting, those who join can expect to have their symptoms and eye health closely monitored to understand how these treatments work. This information could help improve dry eye care in the future.

Gender

ALL

Eligibility criteria

• 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
• • Current punctal plugs or punctal cauterization or occlusion
• • 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