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OpenTrials
Completed

NCT Number: NCT07025811

A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eye Research Foundation, Newport Beach, California, United States

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About this study

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]).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vevye®

Drug

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

Other names: Cyclosporine Ophthalmic Solution

Xiidra®

Drug

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

Other names: Lifitegrast Ophthalmic Solution

Primary outcomes

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

    Time frame: Up to Week 12

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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