Meibomian Gland DysfunctionNCT02618304
Changes of Tear-film Lipid Layer Thickness and Ocular Aberration After Treatment of Meibomian Gland Dysfunction
A study testing Treatment of Meibomian gland dysfunction in people with Meibomian Gland Dysfunction, run by Yonsei University at 1 site in South Korea.
Trial summary
In this study, investigator aim to evaluate the changes of tear-film lipid layer thickness and ocular aberration after treatment of meibomian gland dysfunction. In case of stage 3 or 4 meibomian gland dysfunction, participants will be treated using conventional treatment modalities. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Treatment of Meibomian gland dysfunction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Apr 2015to 19 Feb 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. age over 19 years old, with moderate to severe Meibomian gland dysfunction.
Who cannot join
- patients with history of previous ocular or intraocular surgery
- ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease
- history of intolerance or hypersensitivity to any component of the study medications
- wearing contact lenses during the study period, presence of current punctal occlusion
- pregnancy, lactating women, and children
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, Yonsei Univeristy College of Medicine
Seoul, 03722
About this study
In this study, investigator aim to evaluate the changes of tear-film lipid layer thickness and ocular aberration after treatment of meibomian gland dysfunction. In case of stage 3 or 4 meibomian gland dysfunction, participants will be treated using conventional treatment modalities. Before treatment and after 1 and 2 months of treatment, a variety of ophthalmic examination, tear-film lipid layer thickness, and ocular aberration are going to measured and compared.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Treatment of Meibomian gland dysfunction
- Keywords
- Meibomian gland dysfunction, Lipiview, Tear Lipid Layer
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of Meibomian gland dysfunctionDrug
artificial tears, 3% Diquafosol Tetrasodium eye drops, steroid eye drops, squeezing of meibomian glands, cleansing of eyelids.
| Study group | Role | What they receive |
|---|---|---|
| moderate to severe meibomian gland dysfunction | Experimental | Not described Receives: Drug: Treatment of Meibomian gland dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of tear-film lipid layer thickness after treatment of meibomian gland dysfunction
Measured: 1 and 2 months after treatment of meibomian gland dysfunction
Changes of ocular aberration after treatment of meibomian gland dysfunction
ocular parameters measured by Ray-tracing wavefront aberrometers (i-Trace, Tracey technologies , Texas ,USA)
Measured: 1 and 2 months after treatment of meibomian gland dysfunction
Secondary outcomes (5)
Corneal erosion grade(oxford score)
Measured: 1 and 2 months after treatment of meibomian gland dysfunction
OSDI(ocular surface disease index)
Measured: 1 and 2 months after treatment of meibomian gland dysfunction
Meibomian gland abnormality
measured by physiological parameter (score 0,1,2,3,4)
Measured: 1 and 2 months after treatment of meibomian gland dysfunction
Meibomian quality
measured by physiological parameter (score 0,1,2,3,4)
Measured: 1 and 2 months after treatment of meibomian gland dysfunction
BUT(tear break-up time)
Measured: 1 and 2 months after treatment of meibomian gland dysfunction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start20 Apr 2015
- Primary completion19 Feb 2016
- Study completion19 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 Meibomian Gland DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 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
- NCT02618304
- Sponsor's protocol ID
- 1-2015-0012
- Status last verified
- Jan 2019
- First submitted
- 18 Nov 2015
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Asbell PA, Stapleton FJ, Wickstrom K, Akpek EK, Aragona P, Dana R, Lemp MA, Nichols KK. The international workshop on meibomian gland dysfunction: report of the clinical trials subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2065-85. doi: 10.1167/iovs.10-6997h. Print 2011 Mar. No abstract available.
PubMed 21450920Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. No abstract available.
PubMed 21450919Tomlinson 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 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Tear-film Lipid Layer Thickness and Ocular Aberration After Treatment of Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT02618304
- Acronym / sponsor ID
- 1-2015-0012
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- Meibomian gland dysfunction, Lipiview, Tear Lipid Layer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- 19 Feb 2016 (actual)
- Study completion
- 19 Feb 2016 (actual)
- First posted
- 1 Dec 2015 (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, investigator aim to evaluate the changes of tear-film lipid layer thickness and ocular aberration after treatment of meibomian gland dysfunction. In case of stage 3 or 4 meibomian gland dysfunction, participants will be treated using conventional treatment modalities. Before treatment and after 1 and 2 months of treatment, a variety of ophthalmic examination, tear-film lipid layer thickness, and ocular aberration are going to measured and compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| moderate to severe meibomian gland dysfunction | Experimental | Drug: Treatment of Meibomian gland dysfunction |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. age over 19 years old, with moderate to severe Meibomian gland dysfunction.
Key exclusion criteria (5 listed)
- patients with history of previous ocular or intraocular surgery
- ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease
- history of intolerance or hypersensitivity to any component of the study medications
- wearing contact lenses during the study period, presence of current punctal occlusion
- pregnancy, lactating women, and children
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 |
|---|---|---|
| Treatment of Meibomian gland dysfunctionartificial tears, 3% Diquafosol Tetrasodium eye drops, steroid eye drops, squeezing of meibomian glands, cleansing of eyelids. | Drug | moderate to severe meibomian gland dysfunction |
Primary outcome
Changes of tear-film lipid layer thickness after treatment of meibomian gland dysfunction
Time frame: 1 and 2 months after treatment of meibomian gland dysfunction
Changes of ocular aberration after treatment of meibomian gland dysfunction
Time frame: 1 and 2 months after treatment of meibomian gland dysfunction
ocular parameters measured by Ray-tracing wavefront aberrometers (i-Trace, Tracey technologies , Texas ,USA)
5 secondary outcomes
Corneal erosion grade(oxford score)
Time frame: 1 and 2 months after treatment of meibomian gland dysfunction
OSDI(ocular surface disease index)
Time frame: 1 and 2 months after treatment of meibomian gland dysfunction
Meibomian gland abnormality
Time frame: 1 and 2 months after treatment of meibomian gland dysfunction
Meibomian quality
Time frame: 1 and 2 months after treatment of meibomian gland dysfunction
BUT(tear break-up time)
Time frame: 1 and 2 months after treatment of meibomian gland dysfunction
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 10 Jan 2019.
- Background: PubMed 21450920Asbell PA, Stapleton FJ, Wickstrom K, Akpek EK, Aragona P, Dana R, Lemp MA, Nichols KK. The international workshop on meibomian gland dysfunction: report of the clinical trials subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2065-85. doi: 10.1167/iovs.10-6997h. Print 2011 Mar. No abstract available.
- Background: PubMed 21450919Geerling G, Tauber J, Baudouin C, Goto E, Matsumoto Y, O'Brien T, Rolando M, Tsubota K, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on management and treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2050-64. doi: 10.1167/iovs.10-6997g. 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.
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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?
A study testing Treatment of Meibomian gland dysfunction in people with Meibomian Gland Dysfunction, 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 5 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 10 Jan 2019. 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?
Changes of tear-film lipid layer thickness after treatment of meibomian gland dysfunction (time frame: 1 and 2 months after treatment of meibomian gland dysfunction). The study lists 2 primary outcomes in all. 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 NCT02618304, 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 10 Jan 2019.