Dry eye/meibomian glands dysfunction (MGD) Eye Diseases
Conditions
Interventions
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 pres
Sponsors
Laboratoires Horus Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Kingdom
Contacts
Public ContactKishan Patel
Outcome results
None listed