Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis

Completed

• Conditions: Dry Eye Syndromes; Rheumatoid Arthritis

• Registration Number: NCT02252744
• Lead Sponsor: Western University of Health Sciences

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2014-06
• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-30
• Study Completion: 2014-12
• Results First Submitted: 2015-09-22
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-02
• Last Update Submitted: 2016-02-02
• Results First Posted: 2016-02-03
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• Diagnosed with rheumatoid arthritis
• 18 years old or older
• Speaks and understands English and/or Spanish

Exclusion Criteria

• Unable to provide consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease	1 day