Dry Eye SyndromeNCT03364322
Influencing Factors on Dry Eye Syndrome and Ocular Surface Disease
An observational study of Dry Eye Syndrome and Ocular Surface Disease, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
Trial summary
Dry eye syndrome and ocular surface disease are very important ophthalmologic diseases. It is known that various inducers are involved. However, it is still necessary to study how influencing factors are related to dry eye syndrome and ocular surface disease and how treatment for dry eye syndrome and ocular surface… Read more about this study
- Who is it for?
- Ages 19 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome, Ocular Surface Disease
- What is being tested?
- Observation
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2016to 30 Jun 2017
- 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 19 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ocular discomfort related to DED who visit the Hallym University Kangnam Sacred Heart Hospital between June 2016 and June 2017.
Who may be able to join
- Patients with ocular discomfort related to DED who visit the Hallym University Kangnam Sacred Heart Hospital between June 2016 and June 2017.
Who cannot join
- Subjects who are elderly (≥80 years old) or have an autoimmune disease (e.g., Sjögren's syndrome and systemic lupus erythematosus) are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study for Influencing Factors on Dry Eye Syndrome, Ocular Surface Disease and Treatment
Dry eye syndrome and ocular surface disease are very important ophthalmologic diseases. It is known that various inducers are involved. However, it is still necessary to study how influencing factors are related to dry eye syndrome and ocular surface disease and how treatment for dry eye syndrome and ocular surface disease is helpful.
- Conditions
- Dry Eye Syndrome, Ocular Surface Disease
- Being tested
- Observation
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation
| Study group | Role | What they receive |
|---|---|---|
| Dry eye syndrome | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular surface disease index
The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability.
Measured: 1 day
Secondary outcomes (3)
Tear break-up time
Measured: 1 day
Schirmer tear secretion test
Schirmer tear secretion test (mm) without anesthesia was performed using strip (Color Bar; Eagle vision. Memphis, TN)
Measured: 1 day
Corneal fluorescence staining
Corneal staining with fluorescein solution is graded at the time of the exam on a scale of 0 to 5 using the oxford scoring system with 5 being the most severe staining.
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 posted6 Dec 2017
- Study start1 Jun 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Kangnam Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Joo Shin, Hallym University Kangnam Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364322
- Sponsor's protocol ID
- 2016-06-73
- Status last verified
- Dec 2017
- First submitted
- 25 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study for Influencing Factors on Dry Eye Syndrome, Ocular Surface Disease and Treatment
- ClinicalTrials.gov ID
- NCT03364322
- Acronym / sponsor ID
- 2016-06-73
- Conditions
- Dry Eye Syndrome, Ocular Surface Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hallym University Kangnam Sacred Heart HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 6 Dec 2017 (actual)
- 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 syndrome and ocular surface disease are very important ophthalmologic diseases. It is known that various inducers are involved. However, it is still necessary to study how influencing factors are related to dry eye syndrome and ocular surface disease and how treatment for dry eye syndrome and ocular surface disease is helpful.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dry eye syndrome | – | Other: Observation |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ocular discomfort related to DED who visit the Hallym University Kangnam Sacred Heart Hospital between June 2016 and June 2017.
Key inclusion criteria (1 listed)
- Patients with ocular discomfort related to DED who visit the Hallym University Kangnam Sacred Heart Hospital between June 2016 and June 2017.
Key exclusion criteria (1 listed)
- Subjects who are elderly (≥80 years old) or have an autoimmune disease (e.g., Sjögren's syndrome and systemic lupus erythematosus) are excluded.
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 |
|---|---|---|
| ObservationObservation | Other | Dry eye syndrome |
Primary outcome
Ocular surface disease index
Time frame: 1 day
The ocular surface disease index survey in completed at the time of the exam. This scale ranges from 0 to 100 higher scores representing greater disability.
3 secondary outcomes
Tear break-up time
Time frame: 1 day
Schirmer tear secretion test
Time frame: 1 day
Corneal fluorescence staining
Time frame: 1 day
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 7 Dec 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and Ocular Surface Disease, run by Hallym University Kangnam Sacred Heart Hospital at 1 site in South Korea.
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 1 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 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Ocular surface disease index (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 7 Dec 2017.