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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-06-01

Brief Summary

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Assessor-masked (Single blind, randomized controlled trial comparing the conventional treatment group to an interventional group using 16% Manuka Honey topical eye drops.

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Detailed Description

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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

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Meibomian Gland Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional

Group Type PLACEBO_COMPARATOR

systane eye drops

Intervention Type DEVICE

systane lubricant eye drops

Manuka Honey

Group Type ACTIVE_COMPARATOR

manuka honey 16% eye drops ( Optimel )

Intervention Type DEVICE

16% manuka honey eye drops, australian FDA approved

Interventions

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manuka honey 16% eye drops ( Optimel )

16% manuka honey eye drops, australian FDA approved

Intervention Type DEVICE

systane eye drops

systane lubricant eye drops

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No