Dry Eye Syndromes, Rheumatoid Arthritis
Conditions
Keywords
dry eye disease, rheumatoid arthritis
Brief summary
This study will evaluate the prevalence of dry eye disease in patients diagnosed with rheumatoid arthritis. No treatment is administered in this study.
Detailed description
We investigated the prevalence of dry eye disease in patients diagnosed with rheumatoid arthritis by information sheets and direct recruitment of patients of potential study participants diagnosed with rheumatoid arthritis. Subjective assessment for dry eye disease was performed using Ocular Surface Disease Index (OSDI) questionnaire. The following objective tests of dry eye disease were employed: tear osmolarity (TO), tear break-up time (TBUT), corneal fluorescein staining score and conjunctival lissamine green staining scores using the National Eye Institute-recommended grading system, and Schirmer without anesthetic. The Dry Eye Severity Grading Scheme highlighted by the Dry Eye WorkShop was adapted to quantify dry eye disease severity level.
Interventions
OTHERNo intervention
Sponsors
Allergan
Western University of Health Sciences
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with rheumatoid arthritis * 18 years old or older * Speaks and understands English and/or Spanish
Exclusion criteria
* Unable to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease | 1 day |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RA Patients Adult patients diagnosed with rheumatoid arthritis | 286 |
| Total | 286 |
Baseline characteristics
| Characteristic | RA Patients |
|---|---|
| Age, Continuous | 57.46821 years STANDARD_DEVIATION 13.46821 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 141 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 141 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Gender Female | 243 participants |
| Gender Male | 41 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants |
| Race (NIH/OMB) Asian | 17 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants |
| Race (NIH/OMB) White | 216 Participants |
| Region of Enrollment United States | 286 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 286 |
| serious Total, serious adverse events | 0 / 286 |
Outcome results
Primary
Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA Patients | Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease | 275 participants |