NCT04457648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

2 years

First QC Date

June 26, 2020

Last Update Submit

July 2, 2020

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (1)

  • speed score

    questionnaire

    3 weeks

Study Arms (2)

Conventional

PLACEBO COMPARATOR
Device: systane eye drops

Manuka Honey

ACTIVE COMPARATOR
Device: manuka honey 16% eye drops ( Optimel )

Interventions

manuka honey 16% eye drops ( Optimel )DEVICE

16% manuka honey eye drops, australian FDA approved

Manuka Honey
systane eye dropsDEVICE

systane lubricant eye drops

Conventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meibomian gland dysfunction stage 2-4

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

chinese university of Hong kong

Hong Kong, China

Location

Related Publications (1)

  • 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.

    PMID: 33419788DERIVED

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 7, 2020

Study Start

June 1, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

protocol

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
6 months after completion for 6 months

Locations

CN(1)