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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04457648
Other study ID # MGD1
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 1, 2018
Est. completion date June 1, 2020

Study information

Verified date July 2020
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date June 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
manuka honey 16% eye drops ( Optimel )
16% manuka honey eye drops, australian FDA approved
systane eye drops
systane lubricant eye drops

Locations

Country Name City State
China chinese university of Hong kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary speed score questionnaire 3 weeks
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