Recruiting

Inflammation Reduction

Sponsor:

Rinsada

Code:

NCT07618364

Conditions

Dry Eye Syndromes

Dry Eye

Ocular Surface Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Rinsada

Study Details

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

Study ID

NCT07618364

Start date

Jan 1, 2022

Status verified date

Jun, 2025

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

33 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control eye

experimental: Treatment Eye

Interventions

Rinsada

Irrigation via irrigating eyelid retractor

Primary outcome measure

  • MMP-9 Positivity [ Time Frame: 3 Hours ]

Central Contacts and Locations

Central contacts

Srinivas S Kondapalli

4123243010srini@rinsada.com

Locations

Everett and Hurite Ophthalmic Association

Recruiting

Pittsburgh, Pennsylvania, United States, 15219

Contacts

Srinivas Kondapalli, MD

srini@rinsada.com

More Information

Sponsor

Rinsada

Last update posted

Jun 1, 2026

Last verified

Jun, 2025

Keywords

  • ophthalmology
  • optometry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rinsada on 2026-06-01.