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Completed NCT07025811

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

Conditions: Dry Eye Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 378
Sponsor: Hoffmann-La Roche

Location: Eye Research Foundation Newport Beach California

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 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 * 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 study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07025811). StuddyBuddy aggregates publicly available trial information.