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Dry eye study seeks better ways to measure disease

NCT ID NCT07025811

Knowledge-focused Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This study tracks 378 people with moderate to severe dry eye disease and healthy volunteers to see how signs, symptoms, and biomarkers change after treatment with either Vevye or Xiidra eye drops. The goal is to find better ways to measure the disease and its response to therapy. Participants will receive standard anti-inflammatory eye drops and be monitored over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cyclosporine ophthalmic solution (Vevye) and lifitegrast ophthalmic solution (Xiidra)
What this could lead to
If successful, this study could help doctors better understand and measure dry eye disease, leading to more personalized treatments.
What could go wrong
This is an observational study focused on biomarkers, not a treatment trial. It may not lead to new therapies, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

378 people

The number who actually took part.

Started

Jul 2025

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

dry eye syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye disease

Contacts and locations

Locations

  • Advancing Vision Research, LLC

    Goodlettsville, Tennessee, 37072, United States

  • Andover Eye Associates

    Andover, Massachusetts, 01810, United States

  • Butchertown Clinical Trials

    Louisville, Kentucky, 40206, United States

  • CORE Inc.

    Shelby, North Carolina, 28150, United States

  • Eye Research Foundation

    Newport Beach, California, 92663, United States

  • Oculus Research

    Garner, North Carolina, 27529, United States

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502, United States

  • Total Eyecare, P.A.

    Memphis, Tennessee, 38119, United States

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