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

Last updated: May 5, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

4

Condition

Dry Eye Disease

Dry Eyes

Sjogren's Syndrome

Treatment

Xiidra®

Vevye®

Clinical Study ID

NCT07025811
BP45931
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

A. Inclusion Criteria for Participants with DED:

  • The participant reported dry eye-related ocular symptoms for at least 6 monthsbefore the screening visit

  • The participant must have either used lubricant eye drops regularly OR had thedesire 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 forDED (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

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 punctalcauterization or occlusion by an approach different from punctal plugs

  • Use of ocular anti-inflammatory agents or ocular immunosuppressive agents within 3months prior to screening

  • Any intraocular injections (e.g., intravitreal [IVT] anti-vascular endothelialgrowth factor [VEGF]) within 3 months prior to screening, or such injections plannedfor 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

Study Design

Total Participants: 378
Treatment Group(s): 2
Primary Treatment: Xiidra®
Phase: 4
Study Start date:
July 09, 2025
Estimated Completion Date:
July 31, 2026

Study Description

This study aims to characterize longitudinal changes in signs, symptoms, molecular, and imaging markers of the ocular surface to investigate pathological mechanisms and biomarkers (BMs) of DED after treatment with either of two commercially approved therapeutics (Vevye® [cyclosporine ophthalmic solution], Xiidra® [liftegrast ophthalmic solution]).

Connect with a study center

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Site Not Available

  • Butchertown Clinical Trials

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • Butchertown Clinical Trials

    Louisville 4299276, Kentucky 6254925 40206
    United States

    Site Not Available

  • Andover Eye Associates

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • Andover Eye Associates

    Andover 4929055, Massachusetts 6254926 01810
    United States

    Site Not Available

  • Oculus Research

    Garner, North Carolina 27529
    United States

    Site Not Available

  • CORE Inc.

    Shelby, North Carolina 28150
    United States

    Site Not Available

  • Oculus Research

    Garner 4467657, North Carolina 4482348 27529
    United States

    Site Not Available

  • Advancing Vision Research, LLC

    Goodlettsville, Tennessee 37072
    United States

    Site Not Available

  • Total Eyecare, P.A.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Total Eyecare, P.A.

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg, Virginia 24502-4271
    United States

    Site Not Available

  • Piedmont Eye Center

    Lynchburg 4771075, Virginia 6254928 24502-4271
    United States

    Site Not Available

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