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

Roche

Status and phase: Enrolling; Phase 4

Conditions: Dry Eye Disease

Treatments: Drug: Vevye®; Drug: Xiidra®

Study type: Interventional

Funder types: Industry

Identifiers

NCT07025811

BP45931

Details and patient eligibility

About

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).

Full 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]).

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 3 patient groups

Vevye®

Experimental group

Description:

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.

Treatment:

Drug: Vevye®

Xiidra®

Experimental group

Description:

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.

Treatment:

Drug: Xiidra®

Healthy Cohort

No Intervention group

Description:

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