The Effect of Rinsing on Ocular Inflammation and Symptoms in Patients With Dry Eye Disease
Start Date
1/1/2022
Completion Date
12/1/2027
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.
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Rinsada
Conditions
Locations
Everett and Hurite Ophthalmic Association
Pittsburgh, Pennsylvania 15219
United States