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

NCT07025811 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: BP45931
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 8

Brief 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).

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Corneal Staining as Measured by Sodium Fluorescein

  Up to Week 12

Study Arms (3)

Vevye®

EXPERIMENTAL

Participants 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.

Drug: Vevye®

Xiidra®

EXPERIMENTAL

Participants 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.

Drug: Xiidra®

Healthy Cohort

NO INTERVENTION

Healthy volunteers will be enrolled as a control group and will not receive any treatment.

Interventions

Vevye® DRUG

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

Also known as: Cyclosporine Ophthalmic Solution

Vevye®

Xiidra® DRUG

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

Also known as: Lifitegrast Ophthalmic Solution

Xiidra®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• \- The participant does not have overt clinical signs of DED in either eye

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (8)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Butchertown Clinical Trials

Louisville, Kentucky, 40206, United States

Location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Oculus Research

Garner, North Carolina, 27529, United States

Location

CORE Inc.

Shelby, North Carolina, 28150, United States

Location

Advancing Vision Research, LLC

Goodlettsville, Tennessee, 37072, United States

Location

Total Eyecare, P.A.

Memphis, Tennessee, 38119, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502-4271, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

lifitegrast

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a partially masked study where health care professionals conducting the ocular assessments will be masked to treatment assignment but not to study eye assignment. However, other site personnel and participants will be unmasked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 18, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (8)