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Mr Kishan Patel


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Be Part of Research - Trial Details - Evaluation of eyelid cleansing wipes for dry eye management
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Evaluation of eyelid cleansing wipes for dry eye management

Not Recruiting

Open to: All Genders

Age: Adult

London

Medical Conditions

Dry eye/meibomian glands dysfunction (MGD)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 May 2018 30 Aug 2018

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.


Adults who are at least 18 and who have otherwise healthy eyes with dry eye symptoms

You can take part if:



You may not be able to take part if:


1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate study participation2. Use of systemic or ocular medications that could be contraindicated as determined by the investigator3. Monocular participants (only one eye with functional vision)4. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit5. History of herpetic keratitis, ocular surgery or irregular cornea6. Known pregnancy or lactation during the study period7. 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 individuals8. Participation in any clinical trial within 30 days of the enrolment visit


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

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

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.

Mr Kishan Patel



The study is sponsored by Laboratoires Horus Pharma and funded by Laboratoires Horus Pharma.



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Read full details for Trial ID: ISRCTN18065902
Last updated 07 April 2020

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