Dry Eye Disease
Conditions
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).
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® \[liftegrast ophthalmic solution\]).
Interventions
DRUGVevye®
Participants will receive Vevye® (0.1% cyclosporine ophthalmic solution) as per the schedule described in the treatment arm.
DRUGXiidra®
Participants will receive Xiidra® (5% lifitegrast ophthalmic solution) as per the schedule described in the treatment arm.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Corneal Staining as Measured by Sodium Fluorescein | Up to Week 12 |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed