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

Meibomian Gland Dysfunction Clinical Trial

Official title:

Randomized Assessor Masked Trial Comparing Manuka Honey Eye Drops to Conventional Treatment of Meibomian Gland Dysfunction Related Dry Eye Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04457648
• Other study ID #: MGD1
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

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