Manuka Honey Eye Drops VS Conventional Treatment of Meibo... | NCT04457648

Studies
Manuka Honey Eye Drops VS Conventional Treatment of Meibomian Gland Dysfunction Related Dry Eye Disease

NCT04457648

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Jul 7, 2020Actual

Enrollment

59Actual

Phase

Phase 4

Conditions

Meibomian Gland Dysfunction

Interventions

manuka honey 16% eye drops ( Optimel )
systane eye drops

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Jun 1, 2020Actual

First Submitted Date

Jun 26, 2020

First Submission Date that Met QC Criteria

Jul 2, 2020

First Posted Date

Jul 7, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2020

Last Update Posted Date

Jul 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional	Placebo Comparator		Device: systane eye drops
Manuka Honey	Active Comparator		Device: manuka honey 16% eye drops ( Optimel )

Interventions

Name	Type	Description	Arm Group Labels	Other Names
manuka honey 16% eye drops ( Optimel )	Device	16% manuka honey eye drops, australian FDA approved	Manuka Honey

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
speed score	questionnaire	3 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

meibomian gland dysfunction stage 2-4

Exclusion Criteria:

<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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
chinese university of Hong kong		Hong Kong			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33419788	Derived	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.

ID	Term
D005141	Eyelid Diseases
D005128	Eye Diseases