Meibomian Gland Dysfunction
Conditions
Interventions
Experimental group:Systane iLux treatment
Sponsors
Beijing Tongren Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: Patients must be willing and able to participate in all study visits and assessments 2: Be at least 18 years of age, no gender limitation 3: Abnormal meibum quality (grade=1) 4: Abnormal meibum expressibility (grade=1) 5: A history of MGD/dry eye symptoms for 3 months prior to study enrollment, demonstrated by baseline SPEED scores equal or greater than 6 6: Does not start a regimen of any systemic medication known to cause dry eye (e.g., antihistamines, antidepressants, antipsychotics, benzodiazepines) or meibomian gland dysfunction ophthalmic medications
Exclusion criteria
Exclusion criteria: 1: meibomian gland loss of >50% at screening as evaluated using meibography 2: Patients who have had any type of dry eye or MGD physical therapy apparatus treatment in the past 12 months including but not limited to IPL, iLux and Lipiflow 3: Warm massage or warm expression treatment within 2 weeks before enrollment 4: Patients who are on ocular steroid treatment actively or in the past 30 days 5: Patients who have had a Blephex lid exfoliation treatment within the past 6 months 6: Patients with any type of ocular surgery in the past 6 months 7: Lid surface abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis) that affect lid function in either eye 8: Patients who wear contact lenses who cannot discontinue use 1 week prior to entering the study and continue not to wear them until the final assessment in the study 9: Patients who have ocular trauma, herpetic keratitis, or recurrent ocular inflammation within the past 3 months 10: Patients with punctal plugs or punctal occlusion 11: Patients who had initiated any systemic medications known to cause dry eye (e.g., antihistamines, antidepressants, antipsychotics, benzodiazepines) or nondry eye/ meibomian gland dysfunction ophthalmic medications within 1 month before screening 12: Patients who are not on a stable dose of any dry eye or MGD medication 13: Use of another investigational device or agent within the past month 14: Systemic disease conditions that cause dry eye (e.g., Sjogren syndrome) 15: Active ocular infection, anterior blepharitis, lid abnormalities that affect lid function, limbal stem cell deficiency, ocular/eyelid cicatricial disease or permanent eyelid tattoos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composition of meibum;Meibomian gland secretion score, MGS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Meibum expressibility score (MES);Orifices plugging score (OPS);Tear film lipid layer thickness (LLT);Non-invasive tear breakup time (NITBUT);Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire;Corneal fluorescein staining (CFS); | — |
Countries
China
Contacts
Public ContactYing Jie
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed