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Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02252744
Recruitment Status : Completed
First Posted : September 30, 2014
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Jasmine Yumori, 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.

Condition or disease Intervention/treatment
Dry Eye Syndromes Rheumatoid Arthritis Other: No intervention

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.

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Study Type : Observational
Actual Enrollment : 286 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis
Study Start Date : November 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease [ Time Frame: 1 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosis of rheumatoid arthritis
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Unable to provide consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252744


Sponsors and Collaborators
Western University of Health Sciences
Allergan
Investigators
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Principal Investigator: Jasmine W Yumori, OD FAAO Western University of Health Sciences

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Responsible Party: Jasmine Yumori, Associate Professor, Western University of Health Sciences
ClinicalTrials.gov Identifier: NCT02252744     History of Changes
Other Study ID Numbers: WesternU-12irb027
First Posted: September 30, 2014    Key Record Dates
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jasmine Yumori, Western University of Health Sciences:
dry eye disease
rheumatoid arthritis

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases