Dry Eye SyndromeNCT01942226
Investigation on Medical Management of Dry Eye Patients
An observational study of Dry Eye Syndrome, run by National Cheng Kung University at 2 sites in Taiwan.
Trial summary
Dry eye is a common complaint in patients encountered by ophthalmologists, which may result from the inflammatory response and can occur in the absence of systemic disease. However, the management of dry eye syndrome in real setting warrants assessment but remains lacking in Taiwan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dry Eye Syndrome
- How many people
- 466 participants
- Where
- 2 sitesTaiwan
- Study dates
- Aug 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants from a primary care clinic or a tertiary referral center
Who may be able to join
- Have given a written informed consent
- Clinical diagnosis of dry eye syndrome
- Have at least one Schirmer's test positive result (less than 10mm/5min) in at least one eye within one year
Who cannot join
- Pregnancy
- Cognitive or psychiatric deficit that precludes informed consent
- Cognitive or psychiatric deficit that precludes ability to perform requirements of the investigation
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Sun-Huei Tseng Eye Institute
Tainan, 704
Department of Ophthalmology, National Taiwan University Hospital
Taipei, 101
About this study
Dry eye is a common complaint in patients encountered by ophthalmologists, which may result from the inflammatory response and can occur in the absence of systemic disease. However, the management of dry eye syndrome in real setting warrants assessment but remains lacking in Taiwan. We conducted an perspective observational study to evaluate the medical management of dry eye patients.
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry eye syndrome
- Medical subject headings
- Dry Eye Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Artificial tears utilization patterns
Measured: within 1 month before recruitment
Secondary outcomes (2)
Changes of dry eye symptoms, evaluated by clinicians
Measured by clinical global impression (CGI)
Measured: Baseline
Changes of dry eye symptoms, evaluated by patients
Measured by subject global assessment (SGA)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromeStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 466 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Sun-Huei Tseng Eye Institute, Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University, Tainan, Taiwan, Allergan Pharmaceuticals Taiwan Co., Ltd.
- Responsible party
- Principal investigator, Yea-Huei Kao Yang, National Cheng Kung University
- Investigators
- Yea-Huei Kao Yang, Professor, Principal investigator, Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942226
- Sponsor's protocol ID
- MODE
- Status last verified
- Dec 2013
- First submitted
- 10 Sep 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yeh PT, Chien HC, Ng K, Tseng SH, Chen WL, Hou YC, Wang IJ, Chu HS, Kao Yang YH, Hu FR. Concordance between patient and clinician assessment of dry eye severity and treatment response in Taiwan. Cornea. 2015 May;34(5):500-5. doi: 10.1097/ICO.0000000000000409.
PubMed 25782401
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Medical Management of Dry Eye Patients
- ClinicalTrials.gov ID
- NCT01942226
- Acronym / sponsor ID
- MODE
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry eye syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 466 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Sun-Huei Tseng Eye Institute, Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University, Tainan, Taiwan, Allergan Pharmaceuticals Taiwan Co., Ltd.
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dry eye is a common complaint in patients encountered by ophthalmologists, which may result from the inflammatory response and can occur in the absence of systemic disease. However, the management of dry eye syndrome in real setting warrants assessment but remains lacking in Taiwan. We conducted an perspective observational study to evaluate the medical management of dry eye patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants from a primary care clinic or a tertiary referral center
Key inclusion criteria (3 listed)
- Have given a written informed consent
- Clinical diagnosis of dry eye syndrome
- Have at least one Schirmer's test positive result (less than 10mm/5min) in at least one eye within one year
Key exclusion criteria (3 listed)
- Pregnancy
- Cognitive or psychiatric deficit that precludes informed consent
- Cognitive or psychiatric deficit that precludes ability to perform requirements of the investigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Artificial tears utilization patterns
Time frame: within 1 month before recruitment
2 secondary outcomes
Changes of dry eye symptoms, evaluated by clinicians
Time frame: Baseline
Changes of dry eye symptoms, evaluated by patients
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2013.
- Derived from this study: PubMed 25782401Yeh PT, Chien HC, Ng K, Tseng SH, Chen WL, Hou YC, Wang IJ, Chu HS, Kao Yang YH, Hu FR. Concordance between patient and clinician assessment of dry eye severity and treatment response in Taiwan. Cornea. 2015 May;34(5):500-5. doi: 10.1097/ICO.0000000000000409.
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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.
Yea-Huei Kao Yang, Professor principal investigator
Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndrome, run by National Cheng Kung University at 2 sites in Taiwan.
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 3 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 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Artificial tears utilization patterns (time frame: within 1 month before recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01942226, which also lists 1 linked publication.
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 9 Dec 2013.