Meibomian GlandsNCT01979887
Characterization of Signs and Symptoms of Participants With and Without Meibomian Gland Dysfunction
An observational study of Meibomian Glands, run by Allergan at 2 sites in 2 countries.
Trial summary
This is an exploratory study to evaluate endpoints used to characterize participants with and without meibomian gland dysfunction (MGD) and will evaluate the correlation between signs and symptoms of MGD. No investigational drug will be administered in this study. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Meibomian Glands
- What is being tested?
- Meibum Expression
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2013to Jul 2014
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants characterized as with or without Meibomian Gland Dysfunction.
Who may be able to join
- -Participants characterized as with or without Meibomian Gland Dysfunction.
Who cannot join
- Lid heating therapy, therapeutic gland expression, or meibomian gland probing within 12 months of enrollment
- Contact lens use in the 30 days prior to enrollment
- Lid hygiene within 48 hours prior to enrollment
- Use of eye makeup within 8 hours of enrollment
- Eyelash growth-stimulating products within 30 days prior to enrollment
- Use of systemic vitamins and/or systemic supplements containing omega 3 fatty acids within 60 days of enrollment
- Use of systemic anti-histamines within 30 days prior to enrollment.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This is an exploratory study to evaluate endpoints used to characterize participants with and without meibomian gland dysfunction (MGD) and will evaluate the correlation between signs and symptoms of MGD. No investigational drug will be administered in this study.
- Conditions
- Meibomian Glands
- Being tested
- Meibum Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meibum ExpressionProcedure or surgery
Meibum expression as per protocol. No investigational drug is administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Non-MGD Participants | Participants without MGD who have meibum expressed as per protocol. No investigational drug is administered in this study. Receives: Procedure: Meibum Expression | |
| Mild-Moderate MGD Participants | Participants with Mild-Moderate MGD who have meibum expressed as per protocol. No investigational drug is administered in this study. Receives: Procedure: Meibum Expression | |
| Severe MGD Participants | Participants with Severe MGD who have meibum expressed as per protocol. No investigational drug is administered in this study. Receives: Procedure: Meibum Expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibum Quality Score in the Study Eye as Assessed by the Investigator Using a 4-Point Scale
Measured: Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2014
- Study completionJul 2014
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 GlandsStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979887
- Sponsor's protocol ID
- 195263-007
- Status last verified
- Aug 2014
- First submitted
- 4 Nov 2013
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Nguyen A, Naidoo KK, Ajouz L, Xu X, Zhao C, Robinson MR, Borchman D. Changes in Human Meibum Lipid Composition Related to the Presence and Severity of Meibomian Gland Dysfunction. J Ocul Pharmacol Ther. 2024 Nov;40(9):562-570. doi: 10.1089/jop.2024.0063. Epub 2024 Aug 16.
PubMed 39150383Ajouz L, Hallak J, Naik R, Nguyen A, Zhao C, Robinson MR, Nichols KK. Evaluation of the Impact of Meibomian Gland Dysfunction Using a Novel Patient-Reported Outcome Instrument. J Ocul Pharmacol Ther. 2024 Jan-Feb;40(1):48-56. doi: 10.1089/jop.2023.0080. Epub 2023 Nov 1.
PubMed 37910805Ajouz L, Nguyen A, Zhao C, Robinson MR, Nichols KK. Exploring Signs and Symptoms Associated with Meibomian Gland Dysfunction for Use as Clinical Trial Endpoints. J Ocul Pharmacol Ther. 2023 Nov;39(9):611-621. doi: 10.1089/jop.2023.0064. Epub 2023 Aug 29.
PubMed 37643299Nagar S, Ajouz L, Nichols KK, Kumar S, Zhao C, Naidoo KK, Robinson MR, Borchman D. Relationship Between Human Meibum Lipid Composition and the Severity of Meibomian Gland Dysfunction: A Spectroscopic Analysis. Invest Ophthalmol Vis Sci. 2023 Jul 3;64(10):22. doi: 10.1167/iovs.64.10.22.
PubMed 37466951
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Signs and Symptoms of Participants With and Without Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT01979887
- Acronym / sponsor ID
- 195263-007
- Conditions
- Meibomian Glands
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Nov 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.
This is an exploratory study to evaluate endpoints used to characterize participants with and without meibomian gland dysfunction (MGD) and will evaluate the correlation between signs and symptoms of MGD. No investigational drug will be administered in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-MGD Participants | – | Procedure: Meibum ExpressionParticipants without MGD who have meibum expressed as per protocol. No investigational drug is administered in this study. |
| Mild-Moderate MGD Participants | – | Procedure: Meibum ExpressionParticipants with Mild-Moderate MGD who have meibum expressed as per protocol. No investigational drug is administered in this study. |
| Severe MGD Participants | – | Procedure: Meibum ExpressionParticipants with Severe MGD who have meibum expressed as per protocol. No investigational drug is administered in this study. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants characterized as with or without Meibomian Gland Dysfunction.
Key inclusion criteria (1 listed)
- -Participants characterized as with or without Meibomian Gland Dysfunction.
Key exclusion criteria (7 listed)
- Lid heating therapy, therapeutic gland expression, or meibomian gland probing within 12 months of enrollment
- Contact lens use in the 30 days prior to enrollment
- Lid hygiene within 48 hours prior to enrollment
- Use of eye makeup within 8 hours of enrollment
- Eyelash growth-stimulating products within 30 days prior to enrollment
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 |
|---|---|---|
| Meibum ExpressionMeibum expression as per protocol. No investigational drug is administered in this study. | Procedure or surgery | Mild-Moderate MGD Participants, Non-MGD Participants, Severe MGD Participants |
Primary outcome
Meibum Quality Score in the Study Eye as Assessed by the Investigator Using a 4-Point Scale
Time frame: Day 22
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 15 Aug 2014.
- Derived from this study: PubMed 39150383Nguyen A, Naidoo KK, Ajouz L, Xu X, Zhao C, Robinson MR, Borchman D. Changes in Human Meibum Lipid Composition Related to the Presence and Severity of Meibomian Gland Dysfunction. J Ocul Pharmacol Ther. 2024 Nov;40(9):562-570. doi: 10.1089/jop.2024.0063. Epub 2024 Aug 16.
- Derived from this study: PubMed 37910805Ajouz L, Hallak J, Naik R, Nguyen A, Zhao C, Robinson MR, Nichols KK. Evaluation of the Impact of Meibomian Gland Dysfunction Using a Novel Patient-Reported Outcome Instrument. J Ocul Pharmacol Ther. 2024 Jan-Feb;40(1):48-56. doi: 10.1089/jop.2023.0080. Epub 2023 Nov 1.
- Derived from this study: PubMed 37643299Ajouz L, Nguyen A, Zhao C, Robinson MR, Nichols KK. Exploring Signs and Symptoms Associated with Meibomian Gland Dysfunction for Use as Clinical Trial Endpoints. J Ocul Pharmacol Ther. 2023 Nov;39(9):611-621. doi: 10.1089/jop.2023.0064. Epub 2023 Aug 29.
- Derived from this study: PubMed 37466951Nagar S, Ajouz L, Nichols KK, Kumar S, Zhao C, Naidoo KK, Robinson MR, Borchman D. Relationship Between Human Meibum Lipid Composition and the Severity of Meibomian Gland Dysfunction: A Spectroscopic Analysis. Invest Ophthalmol Vis Sci. 2023 Jul 3;64(10):22. doi: 10.1167/iovs.64.10.22.
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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.
Medical Director study director
Allergan
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meibomian Glands, run by Allergan at 2 sites in 2 countries.
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 7 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 15 Aug 2014. 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 United States, United Kingdom. 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?
Meibum Quality Score in the Study Eye as Assessed by the Investigator Using a 4-Point Scale (time frame: Day 22). 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 NCT01979887, 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 15 Aug 2014.