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RECRUITING
NCT07025811
PHASE4

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

350

Start Date

2025-07-09

Completion Date

2026-04-30

Last Updated

2025-11-04

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Vevye®

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

DRUG

Xiidra®

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

Locations (5)

Butchertown Clinical Trials

Louisville, Kentucky, United States

Andover Eye Associates

Andover, Massachusetts, United States

Oculus Research

Garner, North Carolina, United States

Total Eyecare, P.A.

Memphis, Tennessee, United States

Piedmont Eye Center

Lynchburg, Virginia, United States