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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control eye | No Intervention | ||
| Treatment Eye | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rinsada | Device | Irrigation via irrigating eyelid retractor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Srinivas S Kondapalli | Contact | 4123243010 | srini@rinsada.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Everett and Hurite Ophthalmic Association | Recruiting | Pittsburgh | Pennsylvania | 15219 | United States |
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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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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One patient with one eye being treated and other eye acting as a control
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Outcomes will be read by blinded reader of MMP-9 positivitiy.