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

Completed · Phase 4

Conditions studied: Dry Eye Disease

In brief

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).

Key facts

Study ID

NCT07025811

Run by

Hoffmann-La Roche

People needed

378

Starts

2025-07-09

Expected to finish

2026-07-16

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Eye Research Foundation — Newport Beach, California, United States
• Butchertown Clinical Trials — Louisville, Kentucky, United States
• Andover Eye Associates — Andover, Massachusetts, United States
• Oculus Research — Garner, North Carolina, United States
• CORE Inc. — Shelby, North Carolina, United States
• Advancing Vision Research, LLC — Goodlettsville, Tennessee, United States
• Total Eyecare, P.A. — Memphis, Tennessee, United States
• Piedmont Eye Center — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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