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Trial record 49 of 2725 for:    Rheumatoid Arthritis

Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Dry Eye Syndromes
Rheumatoid Arthritis
Intervention Other: No intervention
Enrollment 286
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RA Patients
Hide Arm/Group Description Adult patients diagnosed with rheumatoid arthritis
Period Title: Overall Study
Started 286
Completed 286
Not Completed 0
Arm/Group Title RA Patients
Hide Arm/Group Description Adult patients diagnosed with rheumatoid arthritis
Overall Number of Baseline Participants 286
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 286 participants
57.46821  (13.46821)
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 286 participants
Female 243
Male 41
[1]
Measure Description: Gender data unavailable for 2 participants
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants
Hispanic or Latino
141
  49.3%
Not Hispanic or Latino
141
  49.3%
Unknown or Not Reported
4
   1.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 286 participants
American Indian or Alaska Native
7
   2.4%
Asian
17
   5.9%
Native Hawaiian or Other Pacific Islander
2
   0.7%
Black or African American
22
   7.7%
White
216
  75.5%
More than one race
0
   0.0%
Unknown or Not Reported
22
   7.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 286 participants
286
1.Primary Outcome
Title Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease
Hide Description [Not Specified]
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RA Patients
Hide Arm/Group Description:
Adult patients diagnosed with rheumatoid arthritis
Overall Number of Participants Analyzed 286
Measure Type: Number
Unit of Measure: participants
275
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RA Patients
Hide Arm/Group Description Adult patients diagnosed with rheumatoid arthritis
All-Cause Mortality
RA Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
RA Patients
Affected / at Risk (%)
Total   0/286 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RA Patients
Affected / at Risk (%)
Total   0/286 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jasmine Wong Yumori OD FAAO
Organization: Western University of Health Sciences
Phone: (909) 706-3886
Responsible Party: Jasmine Yumori, Western University of Health Sciences
ClinicalTrials.gov Identifier: NCT02252744     History of Changes
Other Study ID Numbers: WesternU-12irb027
First Submitted: September 18, 2014
First Posted: September 30, 2014
Results First Submitted: September 22, 2015
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016