Condition category
Eye Diseases
Date applied
06/06/2018
Date assigned
07/06/2018
Last edited
07/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Dry eye or meibomian gland dysfunction (MGD) is a complex condition for which numerous management products have been developed to deal with the many causes of the condition. Dry eye has significant impact on quality of life and is a burden. Many dry eye sufferers use eyedrops to relieve their symptoms. Maintaining good eyelid hygiene with cleansing is considered a mainstay of management for MGD. Incorporating this into the participants daily routine is beneficial. ILAST® WIPES, 0.2% sodium hyaluronate, CE marked cleansing wipes for eyelid hygiene manufactured by Horus Pharma are designed for cleaning eyelids, particularly the inflamed eyelid margin. By removing the deposits, secretions or crusts present on the eyelids and the roots of the eyelashes, the clean eyelids and eyelashes will lessen the dry eye symptoms. The single-use eyelid pre-moistened sterile cleansing wipes will be used to clean both eyelids margin and the base of eyelashes daily in the morning upon waking and in the evening prior to sleep for 1 month. The eyelid cleansing wipes are easy to use and may improve compliance, hence better outcome. Therefore, it is scientifically important to verify that the use of the study eyelid cleansing wipes for dry eye sufferers produces an effect that is an improvement compared to not using them. The aim of this study is to determine the clinical performance of ILAST® WIPES by quantifying the improvement in dry eye symptoms and meibomian gland status after four weeks using the study product.

Who can participate?
Adults who are at least 18 and who have otherwise healthy eyes with dry eye symptoms

What does the study involve?
The participants either use their usual vision correction (spectacles) throughout the study or without correction if they don’t have vision correction and they continue to use their habitual eyedrops as needed. The potential participants attend the clinic for Visit 1 to obtain their informed consent and evaluate their suitability to take part. If the potential participant consents to taking part, vision and ocular (eye) integrity are assessed. The participants are asked to complete symptom questionnaires about eye comfort and dryness. If they fulfil the criteria, measurements and digital photographs of their eyes and eyelids with and without green dye are taken and the study product is provided. They are instructed to use the cleansing wipes in the morning upon waking and at night before sleep every day for 1 month. The study product is for single use only. A new wipe is used for the other eyelid. One month later, participants attend visit 2 where the routine and measurements taken at visit 1 are repeated. The participants’ eyes are examined with a slit-lamp biomicroscope for ocular integrity.

What are the possible benefits and risks of participating?
Participants may not directly benefit from taking part in this study but will have the opportunity to try eyelid cleansing wipes to manage their dry eye symptoms at no cost to them for the duration of the study. The examination and assessments of the front part of the eye are at no cost to participants and can be considered beneficial by documenting their current health status. A possible benefit may also be that using the study eyelid cleansing wipes provides better symptomatic relief to the participant than other products he/she has tried before. Due to the nature and short duration of the study, the risks of participating are considered minimal. The eyelid cleansing wipes will not be instilled in the eyes but swiped across the intact eyelids margin skin and the roots of the eyelashes over closed eyes. This is similar to using face wipes to remove makeup. All the assessments are routine clinical procedures or specialized procedures and none present any increased risk to participants compared with normal clinical care routine.

Where is the study run from?
Ocular Technology Group - International (UK)

When is the study starting and how long is it expected to run for?
April 2018 to December 2018

Who is funding the study?
Laboratoires Horus Pharma (France)

Who is the main contact?
Mr Kishan Patel

Trial website

Contact information

Type

Public

Primary contact

Mr Kishan Patel

ORCID ID

Contact details

66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ID18-18/ HPCLIDM182018001

Study information

Scientific title

Evaluation of eyelid cleansing wipes for meibomian glands dysfunction

Acronym

Study hypothesis

This in an exploratory study hence no hypothesis will be tested.

Ethics approval

London-Riverside Ethics Committee, 27/04/2018, ref: 18/LO/0809

Study design

interventional bilateral single-arm open-label 1-month dispensing study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Dry eye/meibomian glands dysfunction (MGD)

Intervention

ILAST® WIPES sodium hyaluronate 0.2% cleansing wipes for eyelid hygiene are designed for cleaning eyelids, particularly the inflamed eyelid margin. By removing the deposits, secretions or crusts present on the eyelids and the roots of the eyelashes, the clean eyelids and eyelashes will lessen the dry eye symptoms. The single use pre-moistened sterile eyelid cleansing wipes will be used to clean both eyelids margin and the base of eyelashes daily in the morning upon waking and in the evening prior to sleep for 1 month. The eyelid cleansing wipes are easy to use and may improve compliance, hence better outcome.

The study will involve two study visits over a one-month period:
Visit 1: Enrolment/Baseline/Study Product Dispensing ~1.5 hours
Visit 2: Follow up test/discharge visit ~ 1.0 hour (30 ± 3 days from Visit 1)

The potential participants will attend the clinic for Visit 1 to obtain their informed consent and evaluate their suitability to take part in the investigation. If the potential participant consents to taking part, vision and ocular integrity will be assessed. The participants will be asked to complete the symptomatology questionnaires: Ocular Surface Dryness Index-OSDI and Visual Analog Scale-VAS for eye comfort and dryness. If they do not meet the enrolment criteria, they will be discharged. If they fulfil the investigation’s inclusion and exclusion criteria, they will be enrolled, baseline measurements will be done, digital photographs of their eyes and eyelids with and without green dye will be taken and the study product dispensed. They will be instructed to use the cleansing wipes in the morning upon waking and at night prior to sleep every day for one month. The study product is for single use only. A new wipe will be used for the other eyelid. The participants will either use their usual vision correction (spectacles) throughout the study or without correction if they don’t have vision correction and they will continue to use their habitual eyedrops as needed.

One month later, they will then attend the follow-up test/discharge visit 2 where the routine and measurements taken at the enrolment visit 1 will be repeated. The participants’ eyes will be examined with a slit-lamp biomicroscope for ocular integrity. They will be discharged from the study at the end of this visit.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

1. Dry eye symptoms assessed using OSDI questionnaire score at all visits (baseline/dispensing and 1 month)
2. Meibomian glands status assessed using MGD scoring at all visits (baseline/dispensing and 1 month)

Secondary outcome measures

1. Percentage of blocked meibomian glands based on the number of blocked glands observed using slit lamp at all visits (baseline/dispensing and 1 month)
2. Eyelashes contamination grade based on the level of eyelashes contamination observed using slit lamp at all visits (baseline/dispensing and 1 month)

Overall trial start date

17/04/2018

Overall trial end date

17/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. There are no requirements as to participant race or occupation
2. At least 18 years old
3. Have read and understood the Participant Information Sheet
4. Have read, signed and dated the Informed Consent
5. Dry eye sufferers defined by an OSDI symptom score >13
6. Abnormal eyelid margin defined by:
6.1. Meibomian gland dysfunction (MGD) identified by a positive MGD score of Grade 2 or higher; and/or
6.2. Anterior blepharitis identified by eyelash contamination
7. Best corrected visual acuity of at least 20/30 in each eye
8. Have normal eyes with the exception of the need for visual correction
9. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

35 symptomatic dry eye participants to be screened with a view to enroll 30 participants into the study.

Participant exclusion criteria

1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate study participation
2. Use of systemic or ocular medications that could be contraindicated as determined by the investigator
3. Monocular participants (only one eye with functional vision)
4. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit
5. History of herpetic keratitis, ocular surgery or irregular cornea
6. Known pregnancy or lactation during the study period
7. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
8. Participation in any clinical trial within 30 days of the enrolment visit

Recruitment start date

30/05/2018

Recruitment end date

30/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ocular Technology Group - International
66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Sponsor information

Organisation

Laboratoires Horus Pharma

Sponsor details

148
Avenue Georges Guynemer
Cap Var Saint-Laurent du Var
06700
France

Sponsor type

Industry

Website

www.horus-pharma.com/en/

Funders

Funder type

Industry

Funder name

Laboratoires Horus Pharma

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Conference presentation, journal publication.
Details to be confirmed at a later date

Intention to publish date

01/07/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes