Meibomian Gland DysfunctionPhase 4NCT04457648
Manuka Honey Eye Drops VS Conventional Treatment of Meibomian Gland Dysfunction Related Dry Eye Disease
A Phase 4 study testing manuka honey 16% eye drops ( Optimel ) and systane eye drops in people with Meibomian Gland Dysfunction, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Assessor-masked (Single blind, randomized controlled trial comparing the conventional treatment group to an interventional group using 16% Manuka Honey topical eye drops. 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?
- manuka honey 16% eye drops ( Optimel ) and systane eye drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 1 Jun 2020
- Phase
- Phase 4
- 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
- meibomian gland dysfunction stage 2-4
Who cannot join
- <18 years old Unable to consent Recent ophthalmic surgery <6m Abnormalities of lid position Allergy to honey/bee products Contact lens wearers Patients on long term topical medications apart from lubricants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Assessor Masked Trial Comparing Manuka Honey Eye Drops to Conventional Treatment of Meibomian Gland Dysfunction Related Dry Eye Disease.
Assessor-masked (Single blind, randomized controlled trial comparing the conventional treatment group to an interventional group using 16% Manuka Honey topical eye drops.
Read the detailed description
Purpose To evaluate the effects of conventional treatment compared to use of Manuka Honey eye drops in the treatment of meibomian gland dysfunction related dry eye disease.
Design Assessor-masked (Single blind, randomized controlled trial comparing the conventional treatment group to an interventional group using 16% Manuka Honey topical eye drops.
Methods Patients were randomized into two groups, one group given conventional treatment for meibomian gland dysfunction. The other group was given additional manuka honey 16% eye drops which are registered as a medical device by the australian FDA. SPEED score was taken at baseline and upon follow up. Multiple parameters were graded from slit lamp examination by a masked assessor. Results were compared from baseline to follow up date 3 weeks later.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- manuka honey 16% eye drops ( Optimel ), systane eye drops
- 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.
manuka honey 16% eye drops ( Optimel )Device
16% manuka honey eye drops, australian FDA approved
systane eye dropsDevice
systane lubricant eye drops
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Placebo comparator | Not described Receives: Device: systane eye drops |
| Manuka Honey | Active comparator | Not described Receives: Device: manuka honey 16% eye drops ( Optimel ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
speed score
questionnaire
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start1 Jun 2018
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
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.
- More trials run by Chinese University of Hong KongThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Li, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457648
- Sponsor's protocol ID
- MGD1
- Status last verified
- Jul 2020
- First submitted
- 26 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: protocol
Publications
Li AL, Li SL, Kam KW, Young AL. Randomised assessor-masked trial evaluating topical manuka honey (Optimel) in treatment of meibomian gland dysfunction. Br J Ophthalmol. 2022 Jun;106(6):777-780. doi: 10.1136/bjophthalmol-2020-317506. Epub 2021 Jan 8.
PubMed 33419788
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Assessor Masked Trial Comparing Manuka Honey Eye Drops to Conventional Treatment of Meibomian Gland Dysfunction Related Dry Eye Disease.
- ClinicalTrials.gov ID
- NCT04457648
- Acronym / sponsor ID
- MGD1
- Conditions
- Meibomian Gland Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 7 Jul 2020 (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.
Assessor-masked (Single blind, randomized controlled trial comparing the conventional treatment group to an interventional group using 16% Manuka Honey topical eye drops.
Detailed description
Purpose To evaluate the effects of conventional treatment compared to use of Manuka Honey eye drops in the treatment of meibomian gland dysfunction related dry eye disease.
Design Assessor-masked (Single blind, randomized controlled trial comparing the conventional treatment group to an interventional group using 16% Manuka Honey topical eye drops.
Methods Patients were randomized into two groups, one group given conventional treatment for meibomian gland dysfunction. The other group was given additional manuka honey 16% eye drops which are registered as a medical device by the australian FDA. SPEED score was taken at baseline and upon follow up. Multiple parameters were graded from slit lamp examination by a masked assessor. Results were compared from baseline to follow up date 3 weeks later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Placebo comparator | Device: systane eye drops |
| Manuka Honey | Active comparator | Device: manuka honey 16% eye drops ( Optimel ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- meibomian gland dysfunction stage 2-4
Key exclusion criteria (1 listed)
- <18 years old Unable to consent Recent ophthalmic surgery <6m Abnormalities of lid position Allergy to honey/bee products Contact lens wearers Patients on long term topical medications apart from lubricants
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 |
|---|---|---|
| manuka honey 16% eye drops ( Optimel )16% manuka honey eye drops, australian FDA approved | Device | Manuka Honey |
| systane eye dropssystane lubricant eye drops | Device | Conventional |
Primary outcome
speed score
Time frame: 3 weeks
questionnaire
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 Jul 2020.
- Derived from this study: PubMed 33419788Li AL, Li SL, Kam KW, Young AL. Randomised assessor-masked trial evaluating topical manuka honey (Optimel) in treatment of meibomian gland dysfunction. Br J Ophthalmol. 2022 Jun;106(6):777-780. doi: 10.1136/bjophthalmol-2020-317506. Epub 2021 Jan 8.
- Individual participant dataSharing planned: Yes. protocol
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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 Phase 4 study testing manuka honey 16% eye drops ( Optimel ) and systane eye drops in people with Meibomian Gland Dysfunction, run by Chinese University of Hong Kong at 1 site in China.
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 Jul 2020. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
speed score (time frame: 3 weeks). 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 NCT04457648, 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 7 Jul 2020.