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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-09

Study Completion Date

2026-04-30

Brief Summary

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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).

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Detailed Description

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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

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Vevye®

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.

Group Type EXPERIMENTAL

Vevye®

Intervention Type DRUG

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

Xiidra®

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.

Group Type EXPERIMENTAL

Xiidra®

Intervention Type DRUG

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

Healthy Cohort

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vevye®

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

Intervention Type DRUG

Xiidra®

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

Intervention Type DRUG

Other Intervention Names

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Cyclosporine Ophthalmic Solution Lifitegrast Ophthalmic Solution

Eligibility Criteria

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Inclusion Criteria

* 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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes