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

Description

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).

Conditions

Dry Eye Disease
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Related Conditions:

Dry Eye Disease

Study Overview

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Study Details

Study overview

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).

A Longitudinal, Open-label, Multi-center Study to Explore the Relationship Between Signs, Symptoms, Molecular and Imaging Biomarkers in Participants With Dry Eye Disease Following Anti-inflammatory Treatment

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

Condition
Dry Eye Disease
Intervention / Treatment

-

Contacts and Locations

Newport Beach

Eye Research Foundation, Newport Beach, California, United States, 92663

Lynchburg

Piedmont Eye Center, Lynchburg, Virginia, United States, 24502-4271

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Hoffmann-La Roche,

Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

2026-04-30