See if rinsing the eye reduces inflammation and symptoms in severe dry eye

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will evaluate whether irrigation of the bulbar and palpebral conjunctiva, fornices, and corneal surface can reduce inflammatory mediators on the ocular surface in patients with dry eye disease. The primary endpoint is the presence of MMP-9, with secondary measures including the CDES-Q, Ocular Itch Scale, and keratometry. The study aims to enroll 150 participants, with up to 250 screened to achieve the target sample. Participants must have MMP-9 positivity in both eyes and meet other inclusion criteria while excluding active infections, autoimmune ocular surface disease, recent anti-inflammatory therapy, and other ocular conditions. The intervention, Rinsada, will be administered as an eye irrigation procedure. Outcomes will inform whether reducing surface inflammation translates to symptom relief and measurable ocular surface changes.

Why it matters

Who can join: the full rules

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

Where it's running

• Everett and Hurite Ophthalmic Association
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Srinivas S Kondapalli
• Email: srini@rinsada.com
• Phone: 4123243010

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.