Prevalence of Dry Eye Disease in Patients Diagnosed With... | NCT02252744

Studies
Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis

NCT02252744

Sponsor

Western University of Health Sciences

Status

Completed

Last Update Posted

Feb 3, 2016Estimated

Enrollment

286Actual

Phase

Not provided

Conditions

Dry Eye Syndromes
Rheumatoid Arthritis

Interventions

No intervention

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

Participant Flow Module

Pre-assignment Details

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jun 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Sep 18, 2014

First Submission Date that Met QC Criteria

Sep 25, 2014

First Posted Date

Sep 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Sep 22, 2015

Results First Submitted that Met QC Criteria

Feb 2, 2016

Results First Posted Date

Feb 3, 2016Estimated

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2016

Last Update Posted Date

Feb 3, 2016Estimated

Name	Class
Allergan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

286Actual

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with diagnosis of rheumatoid arthritis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jasmine W Yumori, OD FAAO	Western University of Health Sciences	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Title	Description
FG000	RA Patients	Adult patients diagnosed with rheumatoid arthritis

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	RA Patients	Adult patients diagnosed with rheumatoid arthritis

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease

Posted

Number

participants

1 day

ID	Title	Description
OG000	RA Patients	Adult patients diagnosed with rheumatoid arthritis

Units	Counts
Participants	OG000

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RA Patients	Adult patients diagnosed with rheumatoid arthritis

Serious Adverse Events

Not provided

Other Adverse Events

Not provided

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Restriction Type

Point of Contact

Title	Organization	Phone	Extension	Email
Jasmine Wong Yumori OD FAAO	Western University of Health Sciences	(909) 706-3886		jyumori@westernu.edu

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases
D001168	Arthritis
D007592	Joint Diseases

Browse Leaves

Not provided

Browse Branches

Not provided