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

NCT07025811

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Dry Eye Disease

Interventions: Vevye®, Xiidra®

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (8)

Newport Beach, California, United States
Louisville, Kentucky, United States
Andover, Massachusetts, United States
Garner, North Carolina, United States
Shelby, North Carolina, United States
Goodlettsville, Tennessee, United States
Memphis, Tennessee, United States
Lynchburg, Virginia, United States