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Dry Eye DiseasePhase 4NCT07025811

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

A Phase 4 study testing Vevye® and Xiidra® in people with Dry Eye Disease, run by Hoffmann-La Roche at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dry Eye Disease
What is being tested?
Vevye® and Xiidra®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
378 participants
Where
8 sitesUnited States
Study dates
9 Jul 2025to 16 Jul 2026
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
  • Inclusion Criteria for Healthy Volunteers:
  • The participant does not have overt clinical signs of DED in either eye

Who cannot join

  • 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
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  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Andover Eye Associates

    Andover, Massachusetts, 01810

  • Oculus Research

    Garner, North Carolina, 27529

  • Advancing Vision Research, LLC

    Goodlettsville, Tennessee, 37072

  • Butchertown Clinical Trials

    Louisville, Kentucky, 40206

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Total Eyecare, P.A.

    Memphis, Tennessee, 38119

  • Eye Research Foundation

    Newport Beach, California, 92663

  • CORE Inc.

    Shelby, North Carolina, 28150

Other trials in United States

About this study

Official title: 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

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).

Read the detailed 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]).

Conditions
Dry Eye Disease
Being tested
Vevye®, Xiidra®
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vevye®Drug

    Also called Cyclosporine Ophthalmic Solution

    Participants will receive Vevye® (0.1% cyclosporine ophthalmic solution) as per the schedule described in the treatment arm.

  • Xiidra®Drug

    Also called Lifitegrast Ophthalmic Solution

    Participants will receive Xiidra® (5% lifitegrast ophthalmic solution) as per the schedule described in the treatment arm.

Study groups in NCT07025811
Study groupRoleWhat they receive
Vevye®ExperimentalParticipants with evaporative dry eye (EDE), aqueous deficient dry eye (ADDE) and mixed dry eye will receive Vevye®, 1 milligrams per milliliter (mg/mL) as one drop into the affected eye(s), twice daily (BID) via topical ocular instillation for 12 weeks.
Receives: Drug: Vevye®
Xiidra®ExperimentalParticipants with EDE, ADDE, and mixed dry eye will receive Xiidra®, 50 mg/mL as one drop into the affected eye(s), BID via topical ocular instillation for 12 weeks.
Receives: Drug: Xiidra®
Healthy CohortNo interventionHealthy volunteers will be enrolled as a control group and will not receive any treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Corneal Staining as Measured by Sodium Fluorescein

    Measured: Up to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2025
  2. Study start9 Jul 2025
  3. Primary completion16 Jul 2026
  4. Study completion16 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
378 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07025811
Sponsor's protocol ID
BP45931
Status last verified
Jul 2026
First submitted
16 Jun 2025
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

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