Dry Eye SyndromesNCT02252744
Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis
An observational study of Dry Eye Syndromes and Rheumatoid Arthritis, run by Western University of Health Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Rheumatoid Arthritis
- How many people
- 286 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diagnosis of rheumatoid arthritis
Who may be able to join
- Diagnosed with rheumatoid arthritis
- 18 years old or older
- Speaks and understands English and/or Spanish
Who cannot join
- Unable to provide consent
About this study
This study will evaluate the prevalence of dry eye disease in patients diagnosed with rheumatoid arthritis. No treatment is administered in this study.
Read the 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.
- Conditions
- Dry Eye Syndromes, Rheumatoid Arthritis
- Being tested
- No intervention
- Keywords
- dry eye disease, rheumatoid arthritis
- Medical subject headings
- Dry Eye Syndromes, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startNov 2012
- Primary completionJun 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Jasmine Yumori, Western University of Health Sciences
- Investigators
- Jasmine W Yumori, OD FAAO, Principal investigator, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252744
- Sponsor's protocol ID
- WesternU-12irb027
- Status last verified
- Feb 2016
- First submitted
- 18 Sep 2014
- Last updated
- 3 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Dry Eye Disease in Patients Diagnosed With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02252744
- Acronym / sponsor ID
- WesternU-12irb027
- Conditions
- Dry Eye Syndromes, Rheumatoid Arthritis
- Keywords
- dry eye disease, rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Posted 3 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosis of rheumatoid arthritis
Key inclusion criteria (3 listed)
- Diagnosed with rheumatoid arthritis
- 18 years old or older
- Speaks and understands English and/or Spanish
Key exclusion criteria (1 listed)
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | – |
Primary outcome
Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasmine W Yumori, OD FAAO principal investigator
Western University of Health Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndromes and Rheumatoid Arthritis, run by Western University of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Diagnosed With Rheumatoid Arthritis Also Found to Have Dry Eye Disease (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.