NCT07025811

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-09
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2025-06-18
• Last updated: 2025-11-04

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study