Meibomian Gland DysfunctionMGDNCT01870180
EyeBag Effectiveness in Meibomian Gland Dysfunction
A study testing EyeBag in people with Meibomian Gland Dysfunction, run by Aston University at 1 site in United Kingdom.
Trial summary
Meibomian gland dysfunction (MGD) is a common condition that causes the secretion from meibomian glands in the eyelids to become blocked. Normally, the secretion helps to maintain a healthy tear film. In MGD, the tear film becomes unstable and often causes dry eye symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- EyeBag
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2013to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or over
- Have otherwise healthy eyes
- Are prepared not to wear contact lens for the 2 weeks of the trial
- Have a NITBUT <10s
- OSDI score: greater than or equal to 12
- Symptom frequency at least "some of the time"
- Presence of cloudy fluid expressed from at least 1 of the central 8 glands on the lower/upper lid AND/OR presence of poor expressibility from at least 2-3 of the central 8 glands on the lower lid
Who cannot join
- Blepharitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Efficacy of the MGDRx EyeBag in Patients With Meibomian Gland Dysfunction Related Evaporative Dry Eye
Meibomian gland dysfunction (MGD) is a common condition that causes the secretion from meibomian glands in the eyelids to become blocked. Normally, the secretion helps to maintain a healthy tear film. In MGD, the tear film becomes unstable and often causes dry eye symptoms. Treatments often involve gently warming the eyelids to melt this blockage which prevents tears from spreading over the eye. Although there has been some research on application of heat with warm moist flannels, the Eye Bags potentially offers a simpler and more effective method of applying heat to the eyelids. This study will test the efficiency of these eyelid warming devices over a period of two weeks use in one eye compared to the other non-treated eye.
Read the detailed description
Study Design
Contralateral treatment study Randomised eye treated with heated eyebag in the morning and evening each day as per manufacturer's instructions Other eye acts as control with room temperature eyebag overlaid in same manner as treatment eye Investigators masked SMS messaging twice a day for 14 days to remind patients to use eyebag and collect 0-10 comfort score
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- EyeBag, Placebo
- Keywords
- Meibomian Glad Dysfunction, EyeBag, Hot Compress, Dry Eyes
- Medical subject headings
- Meibomian Gland Dysfunction, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeBagDevice
Also called MGDRx EyeBAg
fabric bag of beads which can be heated in a microwave
PlaceboOther
Also called Non-Heated Eyebag
| Study group | Role | What they receive |
|---|---|---|
| EyeBag | Experimental | Eye self-treated with heated eyebag in the morning and evening each day as per manufacturer's instructions (see http://www.eyebagcompany.com/how) Receives: Device: EyeBag |
| Placebo | Placebo comparator | Non-heated EyeBAG: As with eyebag arm but second eyebag applied on other eye at same time BUT not heated Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ocular Symptoms
Ocular symptomology: Ocular Surface Disease Index for right and left eyes
Measured: Between baseline and 2 weeks
Change in Tear Film Quality
Non-invasive tear break up time: 3 measurements per eye
Measured: Between baseline and 2 weeks
Secondary outcomes (3)
Change in Ocular redness
Ocular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured
Measured: Between baseline and 2 weeks
Change in Lipid layer thickness
Tear film lipid layer thickness: for right and left eyes, images captured with Tearscope
Measured: Between baseline and 2 weeks
Change in Meibomian Glands
Meibography: for right and left eyes, images captured using Keratograph 5 leading to change in area score
Measured: Between baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionDec 2014
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 Meibomian Gland DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870180
- Sponsor's protocol ID
- 2013MGD
- Acronym
- MGD
- Status last verified
- Jan 2015
- First submitted
- 24 May 2013
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bilkhu PS, Naroo SA, Wolffsohn JS. Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye. Br J Ophthalmol. 2014 Dec;98(12):1707-11. doi: 10.1136/bjophthalmol-2014-305220. Epub 2014 Jul 4.
PubMed 24997178
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of the MGDRx EyeBag in Patients With Meibomian Gland Dysfunction Related Evaporative Dry Eye
- ClinicalTrials.gov ID
- NCT01870180
- Acronym / sponsor ID
- MGD / 2013MGD
- Conditions
- Meibomian Gland Dysfunction
- Keywords
- Meibomian Glad Dysfunction, EyeBag, Hot Compress, Dry Eyes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Jun 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.
Meibomian gland dysfunction (MGD) is a common condition that causes the secretion from meibomian glands in the eyelids to become blocked. Normally, the secretion helps to maintain a healthy tear film. In MGD, the tear film becomes unstable and often causes dry eye symptoms. Treatments often involve gently warming the eyelids to melt this blockage which prevents tears from spreading over the eye. Although there has been some research on application of heat with warm moist flannels, the Eye Bags potentially offers a simpler and more effective method of applying heat to the eyelids. This study will test the efficiency of these eyelid warming devices over a period of two weeks use in one eye compared to the other non-treated eye.
Detailed description
Study Design
Contralateral treatment study Randomised eye treated with heated eyebag in the morning and evening each day as per manufacturer's instructions Other eye acts as control with room temperature eyebag overlaid in same manner as treatment eye Investigators masked SMS messaging twice a day for 14 days to remind patients to use eyebag and collect 0-10 comfort score
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EyeBag | Experimental | Device: EyeBagEye self-treated with heated eyebag in the morning and evening each day as per manufacturer's instructions (see http://www.eyebagcompany.com/how) |
| Placebo | Placebo comparator | Other: PlaceboNon-heated EyeBAG: As with eyebag arm but second eyebag applied on other eye at same time BUT not heated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 or over
- Have otherwise healthy eyes
- Are prepared not to wear contact lens for the 2 weeks of the trial
- Have a NITBUT <10s
- OSDI score: greater than or equal to 12
Key exclusion criteria (1 listed)
- Blepharitis
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 |
|---|---|---|
| EyeBagAlso: MGDRx EyeBAgfabric bag of beads which can be heated in a microwave | Device | EyeBag |
| PlaceboAlso: Non-Heated Eyebag | Other | Placebo |
Primary outcome
Change in Ocular Symptoms
Time frame: Between baseline and 2 weeks
Ocular symptomology: Ocular Surface Disease Index for right and left eyes
Change in Tear Film Quality
Time frame: Between baseline and 2 weeks
Non-invasive tear break up time: 3 measurements per eye
3 secondary outcomes
Change in Ocular redness
Time frame: Between baseline and 2 weeks
Change in Lipid layer thickness
Time frame: Between baseline and 2 weeks
Change in Meibomian Glands
Time frame: Between baseline and 2 weeks
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 Jan 2015.
- Results publication: PubMed 24997178Bilkhu PS, Naroo SA, Wolffsohn JS. Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye. Br J Ophthalmol. 2014 Dec;98(12):1707-11. doi: 10.1136/bjophthalmol-2014-305220. Epub 2014 Jul 4.
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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 EyeBag in people with Meibomian Gland Dysfunction, run by Aston University at 1 site in United Kingdom.
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 7 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 15 Jan 2015. 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 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. Some participants in this study may receive a placebo. 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?
Change in Ocular Symptoms (time frame: Between baseline and 2 weeks). 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 NCT01870180, 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 15 Jan 2015.