Actively Recruiting
The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease
Led by Rinsada · Updated on 2026-06-01
33
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how rinsing certain parts of the eye might reduce inflammation in people with severe dry eye disease. The study is based on the idea that inflammation worsens dry eye symptoms, and by cleaning the ocular surface, symptoms may improve. This trial aims to better understand the role of inflammation and rinsing in managing dry eye. Participants will receive irrigation treatment using a device called Rinsada which rinses the eyelid and parts of the eye surface including the bulbar and palpebral conjunctiva and conjunctival fornix. The study involves a randomized design comparing the treated eye with a control eye that receives no intervention. The primary measurement is the presence of MMP-9, an inflammatory marker, assessed 3 hours after treatment. During the study, participants will undergo assessments including MMP-9 testing, questionnaires on dry eye symptoms like the CDES-Q and Ocular Itch Scale, and keratometry measurements. Researchers will monitor inflammation levels and symptom changes to evaluate the effect of rinsing. The study plans to enroll 150 patients with severe dry eye, with a total of 250 screened. Participation involves regular visits for testing and follow-up assessments.
CONDITIONS
Brief Title
The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- MMP-9 positivity in both eyes
You will not qualify if you...
- Active ocular infection, including bacterial, viral, or fungal conjunctivitis
- Acute allergic conjunctivitis or severe seasonal ocular allergy flare
- History of autoimmune ocular surface disease such as Sjögren syndrome, ocular cicatricial pemphigoid, or Stevens-Johnson syndrome
- Current use of topical anti-inflammatory medications including corticosteroids, cyclosporine, lifitegrast, or topical NSAIDs within 14 to 30 days prior to enrollment
- Initiation of new ocular or systemic anti-inflammatory therapy during the study period
- Contact lens wear within 12 to 24 hours prior to testing
- Ocular surgery or laser procedures within the previous 3 to 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment with assessments 3 hours post-treatment
Participants receive irrigation of the eye surface to reduce inflammation associated with dry eye disease.
1 treatment visit and 1 follow-up visit 3 hours later (in-person)
Trial Site Locations
Total: 1 location
1
Everett and Hurite Ophthalmic Association
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
Research Team
S
Srinivas S Kondapalli
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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