RECRUITING

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

Talk to us

Conditions

Dry Eye Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2025-07-31
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07025811

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The participant reported dry eye-related ocular symptoms for at least 6 months before the screening visit
  2. * The participant must have either used lubricant eye drops regularly OR had the desire to use lubricant eye drops in the past 3 months
  3. * Participant must be classified as having moderate/severe DED
  4. * The participant is deemed by the physician to require a prescription medication for DED (e.g., cyclosporin A or lifitegrast)
  1. * Intraocular pressure (IOP) \>21.00 millimeters of mercury (mmHg) in either eye
  2. * Acute allergic conjunctivitis in either eye within 3 months prior to screening
  3. * Use of contact lenses within 30 days prior to screening
  4. * Current punctal plugs or punctal cauterization or occlusion
  5. * Use of ocular anti-inflammatory agents or ocular immunosuppressive agents within 3 months prior to screening
  6. * 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
  7. * Any intraocular immunosuppressive implants within 12 months prior to screening
  8. * Any history of isotretinoin use within 12 months prior to screening
  9. * Uncontrolled ocular or systemic disease

Contacts and Locations

Study Contact

Reference Study ID Number: BP45931 https://forpatients.roche.com/
CONTACT
888-662-6728 (U.S.)
global-roche-genentech-trials@gene.com

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Eye Research Foundation
Newport Beach, California, 92663
United States
Piedmont Eye Center
Lynchburg, Virginia, 24502-4271
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-31
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2025-07-31
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Dry Eye Disease