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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02252744
Other study ID # WesternU-12irb027
Secondary ID
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


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
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