Primary Objective \- To assess the proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity. Secondary Objectives * To assess corneal sensitivity via Cochet-Bonnet esthesiometer. * To assess tear secretion via Schirmer I test. * To assess Ocular Pain Assessment Survey (OPAS) questionnaire results.
This observational clinical study has been designed to evaluate the proportion of patients with confirmed Sjögren's dry eye who presented with neurosensory abnormalities via demonstration of increased ocular pain and/or a decrease in corneal sensitivity. A multicenter design allowed for a greater diversity of patient population with Sjögren's dry eye. The number of sites allowed for quick enrollment and expedited results that helped physicians understand the corneal sensitivity levels in the population of patients with Sjögren's dry eye. This study design was minimally invasive and might be completed in a single visit provided all qualification criteria were met. This design reduced the time commitment from patients, thereby reducing barriers for enrollment and participation. Only one eye (study eye) was analyzed for endpoints; if both eyes qualified for the study, the eye with the worse staining (per National Eye Institute \[NEI\] scale) was the study eye. If staining was equal between eyes, the right eye was the study eye. Please note that no safety monitoring was captured, as this was an observational and descriptive study, and no study drug was administered. All testing and procedures conducted in this study were performed consistent with clinical practice standards and should not pose any additional risk to patients.
Study Type
OBSERVATIONAL
Enrollment
103
observational study
West Coast Eye Institute
Bakersfield, California, United States
University of Colorado
Aurora, Colorado, United States
Bowden Eye
Jacksonville, Florida, United States
The proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity
The number and proportion of patients with Sjögren's dry eye who have decreased corneal sensitivity, as determined by Cochet-Bonnet esthesiometer, will be shown with the 95% CI (Wilson method).
Time frame: Visit 1 (Day 1)
Corneal sensitivity, as measured via Cochet-Bonnet esthesiometer.
Summary statistics for continuous and categorical variables will be used to assess the secondary endpoints. Any statistical testing will be descriptive in nature.
Time frame: Visit 1 (Day 1)
Tear secretion, as measured via Schirmer I test.
Summary statistics for continuous and categorical variables will be used to assess the secondary endpoints. Any statistical testing will be descriptive in nature.
Time frame: Visit 1 (Day 1)
OPAS questionnaire results.
Summary statistics for continuous and categorical variables will be used to assess the secondary endpoints. Any statistical testing will be descriptive in nature.
Time frame: Visit 1 (Day 1)
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