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