Dry eye/Meibomian Glands Dysfunction (MGD) Eye Diseases Dry eye/Meibomian Glands Dysfunction (MGD)
Conditions
Interventions
Emulsion eyedrop containing 0.18% sodium hyaluronate, phospholipids, triglycerides and alpha lipoic targets all three layers of the tear film, as well as being hypoosmolar hence addressing the inflamm
Sponsors
Laboratoires Horus Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 years 2. Moderate to severe dry eye sufferers defined by an OSDI score > 23 3. Be willing to stop using habitual eyedrops two days prior to the first study visit 4. Best corrected visual acuity of at least 20/30 in each eye 5. Have read and understood the Participant Information Sheet and Informed Consent in English 6. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
Exclusion criteria
Exclusion criteria: 1. Contact lens wearers 2. Severe ocular dryness with one of the conditions; eyelid or blinking malfunction, corneal disorders not related to dry eye syndrome, ocular metaplasia, filamentous keratitis, corneal neovascularization 3. Current user of the study products 4. Ocular anterior segment infection, inflammation, abnormality, or active disease within the last 12 months not related to dry eye that would contraindicate study participation 5. Use of systemic or ocular medications (such as isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctal plugs) or dry eye therapy (intense pulse light, stem cells) that could be contraindicated as determined by the investigator 6. Monocular participants (only one eye with functional vision) 7. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit 8. History of herpetic keratitis, ocular surgery or irregular cornea 9. Known pregnancy or lactation during the study period 10. 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 11. Participation in any clinical trial within 30 days of the enrollment visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Tear film characteristics using non-invasive digital recording of the tear film using the Tearscope lighting and the slit-lamp at all visits 2. Subjective comfort ratings using visual analog scale (VAS) 0-100 at all visits | — |
Countries
England, United Kingdom
Contacts
Public ContactKishan Patel
Outcome results
None listed