Dry Eye SyndromesRINSE-ANCT07618364
The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease
A study testing Rinsada in people with Dry Eye Syndromes and Dry Eye, run by Rinsada at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes, Dry Eye, Ocular Surface Disease
- What is being tested?
- Rinsada
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- MMP-9 Positivity in both eyes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Everett and Hurite Ophthalmic Association
Pittsburgh, Pennsylvania, 15219
Srinivas Kondapalli, MD, srini@rinsada.com
About this study
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.
Read the detailed 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.
- Conditions
- Dry Eye Syndromes, Dry Eye, Ocular Surface Disease
- Being tested
- Rinsada
- Keywords
- ophthalmology, optometry
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RinsadaDevice
Irrigation via irrigating eyelid retractor
| Study group | Role | What they receive |
|---|---|---|
| Control eye | No intervention | Not described |
| Treatment Eye | Experimental | Not described Receives: Device: Rinsada |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jan 2022
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One patient with one eye being treated and other eye acting as a control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rinsada
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618364
- Sponsor's protocol ID
- R002a
- Acronym
- RINSE-A
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Individual participant data (IPD) will not be shared due to the small sample size and the potential risk of participant re-identification.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT07618364
- Acronym / sponsor ID
- RINSE-A / R002a
- Conditions
- Dry Eye Syndromes, Dry Eye, Ocular Surface Disease
- Keywords
- ophthalmology, optometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- RinsadaIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- One patient with one eye being treated and other eye acting as a control
| Arm | Type | Receives |
|---|---|---|
| Control eye | No intervention | – |
| Treatment Eye | Experimental | Device: Rinsada |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- MMP-9 Positivity in both eyes
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RinsadaIrrigation via irrigating eyelid retractor | Device | Treatment Eye |
Primary outcome
MMP-9 Positivity
Time frame: 3 Hours
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will not be shared due to the small sample size and the potential risk of participant re-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rinsada in people with Dry Eye Syndromes and Dry Eye, run by Rinsada at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Srinivas S Kondapalli (4123243010, srini@rinsada.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMP-9 Positivity (time frame: 3 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.