Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02252744
• Other study ID #: WesternU-12irb027
• Status: Completed
• Phase: N/A
• First received: September 18, 2014
• Last updated: February 2, 2016
• Start date: November 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: Western University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study will evaluate the prevalence of dry eye disease in patients diagnosed with rheumatoid arthritis. No treatment is administered in this study.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Rheumatoid Arthritis

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Western University of Health Sciences	Allergan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease		1 day	No