Condition category
Eye Diseases
Date applied
06/02/2017
Date assigned
21/02/2017
Last edited
14/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dry eye disease is a common medical condition that occurs when the eyes do not make enough tears or the tears evaporate too quickly. This leads to the eyes becoming dry, red, and irritated. Symptoms include dryness, grittiness, soreness, burning, and temporarily blurred vision which usually improves after blinking. Blinking naturally helps express meibum (oil) from healthy meibomian glands in the eyelids. If these glands are blocked, the eyes become dry and the glands may eventually atrophy (waste away). Treatment to unblock the glands involves eyelid massage. This encourages meibum to flow from the glands and allows the eye surface to function normally. Clinical evidence indicates that tear film stability can be improved by expression of the meibomian glands by eyelid massage. However, there is a need for a hygienic and effective eyelid-massaging tool. Anecdotal evidence suggests that dry eye patients most frequently use their fingers to massage their eyelids in an incorrect and ineffective manner and this is one of the first studies to address this issue. The aim of this study is test an eyelid-massaging device along with a heated eye mask over a period of 3 months.

Who can participate?
Patients aged 18 or over with dry eye disease due to meibomian gland dysfunction

What does the study involve?
Participants are randomly allocated into two groups. Participants in the test group use an ‘Eyepeace’ eyelid massager along with a heated eye mask once daily for a period of 3 months. Participants in the control group use a non-heated (room temperature) eye mask once daily for a period of 3 months. The participants can keep the eyelid massager and the eye mask after the end of the study. All participants undergo eye examinations at the start of the study and after 2 weeks, 1 month, 2 months and 3 months.

What are the possible benefits and risks of participating?
The results will increase knowledge of dry eye disease which may benefit people in the future. Eyelid massage and heated eye masks are a safe and non-invasive technique to improve eye health. An allergy questionnaire is used at the start of the study to help identify and minimise any possible risks.

Where is the study run from?
Cathedral Eye Clinic (UK)

When is the study starting and how long is it expected to run for?
April to November 2017

Who is funding the study?
Cathedral Eye Clinic (UK)

Who is the main contact?
Prof. Jonathan Moore

Trial website

www.cathedraleye-research.co.uk

Contact information

Type

Scientific

Primary contact

Prof Jonathan Moore

ORCID ID

http://orcid.org/0000-0001-8451-9421

Contact details

9-91 Academy Street
Belfast
BT1 2LS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v-3

Study information

Scientific title

Investigating the efficacy of the Eyepeace eyelid massager in patients with meibomian gland dysfunction related evaporative dry eye

Acronym

Study hypothesis

Dry eye that occurs in patients with meibomian gland dysfunction is secondary to increased evaporation associated with decreased function of meibomian glands. Therefore expression of the meibomian glands with the Eyepeace eyelid massager will improve their dry eye condition.

Ethics approval

Not provided at time of registration

Study design

Randomized parallel-assigned single-blind (investigator) treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

See additional files

Condition

Meibomian gland dysfunction

Intervention

Participants are randomised by random number generation to one of two groups (the researcher who tests the patients will not know whether they belong to the study group or control group):
1. Participants receive an ‘Eyepeace’ eyelid massager and heated eye mask (2 mins in a warm cup of water) on both eyes (test group) once daily
2. Participants receive a non-heated eye mask (control group) and use it once daily.
All participants are instructed to use the treatment at the same time (morning) for 3 months. All participants undergo eye examinations at enrolment, baseline, and 2 weeks, 1 month, 2 months and 3 months after starting treatment.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Tear film lipid layer thickness for right and left eyes, measured using images captured with Tearscope at 2 weeks, 1 month, 2 months and 3 months

Secondary outcome measures

Measured at baseline, 2 weeks, 1 month, 2 months and 3 months:
1. Tear film quality, measured as non-invasive tear break up time using a slit-lamp-mounted TearScope on each eye in random order
2. Meibomian gland function, based upon meibum quality and expressibility using a slit-lamp following firm digital pressure to the eyelid margins
3. Ocular redness/hyperaemia, measured using images captured non-invasively using a digital slit-lamp photography of the limbal and temporal conjunctiva for both eyes
4. Tear osmolarity for right and left eyes, measured using TearLab
5. Corneal sensitivity for right and left eyes, measured using handheld esthesiometer (Cochet-Bonnet)
6. Corneal staining for right and left eyes, assessed via instillation of lissamine green and fluorescein sodium and using the Oxford corneal grading score
7. Dry eye symptoms for right and left eyes, measured using the Ocular Surface Disease Index
8. Visual satisfaction, measured with Quality of Vision (QOV) questionnaire scores
9. Longitudinal progress of the patient’s dry eye symptoms and adherence to dry eye treatment, measured with the D-III questionnaire

Overall trial start date

01/04/2017

Overall trial end date

01/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Have otherwise healthy eyes
3. Are prepared not to wear contact lens for 3 months of the trial
4. Have a NITBUT <10s
5. OSDI score: greater than or equal to 12
6. Symptom frequency at least "some of the time"
7. Presence of cloudy fluid expressed from at least 1 of the central 8 glands on the lower/upper lid AND/OR presence of poor expressibility from at least 2-3 of the central 8 glands on the lower lid

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 total; 50 participants test group, 50 participants control group. Taking into consideration the possibility of 10-15 dropouts participants in each group.

Participant exclusion criteria

1. Conjunctivitis
2. Meibomian cysts
3. Styes
4. Damage to the cornea
5. Ocular injury
6. Cataract or laser refractive surgery in the past 6-months
7. Increased intraocular pressure (primary or secondary)
8. Any chronic disease of the eye

Recruitment start date

01/06/2017

Recruitment end date

01/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cathedral Eye Clinic
Belfast
BT1 2LS
United Kingdom

Sponsor information

Organisation

Cathedral Eye Clinic

Sponsor details

89-91 Academy Street
Belfast
BT1 2LS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Cathedral Eye Clinic

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers of this study plan to publish the results in a health journal so others can read about and learn from the results of the study.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Jonathan Moore.

Intention to publish date

01/11/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/03/2017: Participant information sheet uploaded.