The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease

NCT07618364 | Recruiting FDA Device

• 1 other identifier: R002a
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Syndromes; Dry Eye; Ocular Surface Disease

Keywords

ophthalmology; optometry

Outcome Measures

Primary Outcomes (1)

• MMP-9 Positivity

  Tear MMP-9 levels will be assessed using a point-of-care diagnostic assay. Change from baseline to the specified follow-up visit will be analyzed.

  3 Hours

Study Arms (2)

Control eye

NO INTERVENTION

Treatment Eye

EXPERIMENTAL

Device: Rinsada

Interventions

Rinsada DEVICE

Irrigation via irrigating eyelid retractor

Treatment Eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MMP-9 Positivity in both eyes

You may not qualify if:

• 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

Sponsors & Collaborators

• Rinsada: lead

Study Sites (1)

Everett and Hurite Ophthalmic Association

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Srinivas S Kondapalli

CONTACT

4123243010; srini@rinsada.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes will be read by blinded reader of MMP-9 positivitiy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One patient with one eye being treated and other eye acting as a control

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: June 1, 2026
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 1, 2026

Record last verified: 2025-06

Locations

US (1)