The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease (RINSE-A)

Rinsada

Status

Enrolling

Conditions

Dry Eye

Dry Eye Syndromes

Ocular Surface Disease

Treatments

Device: Rinsada

Study type

Interventional

Funder types

Industry

Identifiers

NCT07618364

R002a

Details and patient eligibility

About

The central hypothesis is that inflammation contributes to dry eye and that rinsing the palpebral conjunctiva, bulbar conjunctiva, and fornices will reduce the inflammatory burden on the ocular surface.

Full description

The objective is to determine whether irrigation of the bulbar conjunctiva, palpebral conjunctiva, conjunctival fornix, and the corneal surface reduces the inflammatory burden in patients with dry eye disease. The scientific premise is that inflammation contributes to the clinical symptoms of dry eye disease. By reducing the inflammatory mediators on the ocular surface, there may be a reduction in dry eye symptoms.

The primary endpoint is MMP-9 positivity. Secondary endpoints include CDES-Q, Ocular Itch Scale, and keratometry measurements.

The study population includes participants who have severe dry eye disease. The inclusion and exclusion criteria is described below. The goal is to recruit 150 patients, Including screen failures, a total of 250 participants will need to be screened for the study.

Enrollment

33 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

MMP-9 Positivity in both eyes

Exclusion criteria

Active ocular infection, including bacterial, viral, or fungal conjunctivitis Acute allergic conjunctivitis or severe seasonal ocular allergy flare History of autoimmune ocular surface disease (e.g., Sjögren syndrome, ocular cicatricial pemphigoid, Stevens-Johnson syndrome) Current use of topical anti-inflammatory medications, including corticosteroids, cyclosporine, lifitegrast, or topical NSAIDs within 14-30 days prior to enrollment Initiation of new ocular or systemic anti-inflammatory therapy during the study period Contact lens wear within 12-24 hours prior to testing Ocular surgery or laser procedures within the previous 3-6 months Current punctal plug use or punctal occlusion procedures within the prior 3 months Severe aqueous-deficient dry eye preventing adequate tear sample acquisition or reliable InflammaDry testing Use of preserved artificial tears within a specified washout period Eyelid abnormalities or active blepharitis requiring treatment Pregnancy or breastfeeding (optional depending on IRB requirements) History of hypersensitivity to saline irrigation or study materials Any systemic inflammatory disease judged by investigators to confound tear film MMP-9 level