Dry Eye SyndromeNCT02645045
Evaluation of Factors Affecting the Tear-film Lipid Layer Thickness
An observational study of Dry Eye Syndrome, run by Yonsei University at 1 site in South Korea.
Trial summary
In this study, the investigators aim to determine the effects of age, sex, history of ocular surgery and contact lens use, and ocular surface and meibomian gland parameters on the lipid layer thickness (LLT) in normal subjects and patients with dry eye syndrome. Read more about this study
- Who is it for?
- Ages 19 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- How many people
- 350 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Dec 2015to 10 Feb 2016
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: age over 19 years old, Patients with dry eye syndrome and normal subjects
Who may be able to join
- 1. age over 19 years old, Patients with dry eye syndrome and normal subjects
Who cannot join
- patients less than 18 years of age and patients with histories of ocular surgery within 3 months; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease; and patients with the use of a punctal plug or topical ocular medications other than artificial tears.
- Patients who used artificial tears were instructed not to apply them for at least 12 hours 99 before the examinations
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, Yonsei Univeristy College of Medicine
Seoul, Seoul, 03722
About this study
In this study, the investigators aim to determine the effects of age, sex, history of ocular surgery and contact lens use, and ocular surface and meibomian gland parameters on the lipid layer thickness (LLT) in normal subjects and patients with dry eye syndrome. Patients with dry eye syndrome and subjects with a healthy ocular surface will be enrolled. All participant will underwent LLT measurement with a LipiView interferometer, tear meniscus height measurement using optical coherence tomography, tear film break-up time (TBUT) determination, corneal and conjunctival staining, Schirmer's test, examination of the lid margins and meibomian glands, and assessment using the Ocular Surface Disease Index(OSDI) questionnaire.
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry eye, Lipiview, Tear Lipid Layer, meibomian gland dysfunction
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dry eye | Patients with dry eye syndrome | |
| normal | Patients without dry eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Lipid Layer thickness measurement with a LipiView interferometer
Measured: 1 day
Secondary outcomes (6)
tear meniscus height measurement using optical coherence tomography
Measured: 1 day
Corneal and conjunctival erosion grade(oxford score)
Measured: 1 day
tear film break-up time (TBUT)
Measured: 1 day
Schirmer's test (lacrimal secretion test)
Measured: 1 day
evaluation of the score of lid margins and meibomian glands
Measured: 1 day
Ocular Surface Disease Index(OSDI) questionnaire
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 posted1 Jan 2016 (estimated)
- Study start11 Dec 2015
- Primary completion10 Feb 2016
- Study completion10 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645045
- Sponsor's protocol ID
- 4-2015-1009
- Status last verified
- Jan 2017
- First submitted
- 28 Dec 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: no plan to share IPD
Publications
Hom MM, Martinson JR, Knapp LL, Paugh JR. Prevalence of Meibomian gland dysfunction. Optom Vis Sci. 1990 Sep;67(9):710-2. doi: 10.1097/00006324-199009000-00010.
PubMed 2234831Knop E, Knop N, Millar T, Obata H, Sullivan DA. The international workshop on meibomian gland dysfunction: report of the subcommittee on anatomy, physiology, and pathophysiology of the meibomian gland. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1938-78. doi: 10.1167/iovs.10-6997c. Print 2011 Mar. No abstract available.
PubMed 21450915Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.
PubMed 21450918McCulley JP, Shine WE. The lipid layer of tears: dependent on meibomian gland function. Exp Eye Res. 2004 Mar;78(3):361-5. doi: 10.1016/s0014-4835(03)00203-3.
PubMed 15106913
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Factors Affecting the Tear-film Lipid Layer Thickness
- ClinicalTrials.gov ID
- NCT02645045
- Acronym / sponsor ID
- 4-2015-1009
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry eye, Lipiview, Tear Lipid Layer, meibomian gland dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 11 Dec 2015 (actual)
- Primary completion
- 10 Feb 2016 (actual)
- Study completion
- 10 Feb 2016 (actual)
- First posted
- 1 Jan 2016 (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.
In this study, the investigators aim to determine the effects of age, sex, history of ocular surgery and contact lens use, and ocular surface and meibomian gland parameters on the lipid layer thickness (LLT) in normal subjects and patients with dry eye syndrome. Patients with dry eye syndrome and subjects with a healthy ocular surface will be enrolled. All participant will underwent LLT measurement with a LipiView interferometer, tear meniscus height measurement using optical coherence tomography, tear film break-up time (TBUT) determination, corneal and conjunctival staining, Schirmer's test, examination of the lid margins and meibomian glands, and assessment using the Ocular Surface Disease Index(OSDI) questionnaire.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry eye | – | –Patients with dry eye syndrome |
| normal | – | –Patients without dry eye |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- age over 19 years old, Patients with dry eye syndrome and normal subjects
Key inclusion criteria (1 listed)
- 1. age over 19 years old, Patients with dry eye syndrome and normal subjects
Key exclusion criteria (2 listed)
- patients less than 18 years of age and patients with histories of ocular surgery within 3 months; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease; and patients with the use of a punctal plug or topical ocular medications other than artificial tears.
- Patients who used artificial tears were instructed not to apply them for at least 12 hours 99 before the examinations
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
Tear Lipid Layer thickness measurement with a LipiView interferometer
Time frame: 1 day
6 secondary outcomes
tear meniscus height measurement using optical coherence tomography
Time frame: 1 day
Corneal and conjunctival erosion grade(oxford score)
Time frame: 1 day
tear film break-up time (TBUT)
Time frame: 1 day
Schirmer's test (lacrimal secretion test)
Time frame: 1 day
evaluation of the score of lid margins and meibomian glands
Time frame: 1 day
Ocular Surface Disease Index(OSDI) questionnaire
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 25 Jan 2017.
- Background: PubMed 2234831Hom MM, Martinson JR, Knapp LL, Paugh JR. Prevalence of Meibomian gland dysfunction. Optom Vis Sci. 1990 Sep;67(9):710-2. doi: 10.1097/00006324-199009000-00010.
- Background: PubMed 21450915Knop E, Knop N, Millar T, Obata H, Sullivan DA. The international workshop on meibomian gland dysfunction: report of the subcommittee on anatomy, physiology, and pathophysiology of the meibomian gland. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1938-78. doi: 10.1167/iovs.10-6997c. Print 2011 Mar. No abstract available.
- Background: PubMed 21450918Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.
- Background: PubMed 15106913McCulley JP, Shine WE. The lipid layer of tears: dependent on meibomian gland function. Exp Eye Res. 2004 Mar;78(3):361-5. doi: 10.1016/s0014-4835(03)00203-3.
- Individual participant dataSharing planned: No. no plan to share IPD
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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, run by Yonsei University 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 2 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 25 Jan 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?
Tear Lipid Layer thickness measurement with a LipiView interferometer (time frame: 1 day). 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 NCT02645045, which also lists 4 linked publications.
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 25 Jan 2017.