meibomian gland dysfunction meibomian gland dysfunction Dry Eye Dry Eye Disease Evaporative Dry Eye Evaporative Dry Eye Disease Evaporative Dry Eye Syndrome Curcumin Diferuloylmethane Turmeric Yellow Tea tree oil Melaleuca alternifolia Oil
Conditions
Interventions
The foundation of the new tea-tree oil eyelid cleanser was studied and based upon OcuSOFT Lid Scrub Original Eyelid Cleanser (OcuSOFT Inc., TX, USA), approved by the Thai FDA as a cosmetic product. Th
Experimental Drug,Active Comparator Drug
Tea-tree oil eyelid cleanser,OCuSOFT Lid Scrub Original Eyelid Cleanser (OcuSOFT Inc., TX, USA)
Sponsors
Office of Research Affairs
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Phase I 1. Healthy adult aged 18-50 years who are currently working at the King Memorial Chulalongkorn Hospital Phase II 1. non-invasive tear breakup time <10 seconds, 2. at least 1 clinical sign of meibomian gland dysfunction from each category 2.1 meibomian gland dropout, 2.2 altered meibomian gland expression, 2.3 changes in lid morphology
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to known components in the new tea-tree oil eyelid cleanser, OcuSOFT eyelid cleanser 2. Participants with previously diagnosed MGD who have had office lid cleansing treatment, intense pulse light therapy, or home lid hygiene within 1 month prior to the trial will excluded. 3. Pregnant patients are excluded due to lack of embryotoxicity study. 4. Participants with pre-existing diseases of eyelid, conjunctiva, cornea that risk being endangered by application of the cleansers or potentially compromise the study results, as following: - Acquired eyelid disorders, including chalazion, hordeolum, and eyelid neoplasm - Periocular malposition, including ectropion, entropion, symblepharon, trichiasis, distichiasis, eyelid retraction, and exposure keratopathy - Degenerative disorder of conjunctiva, including pinguecula, pterygium - Inflammatory disorders of cornea or systemic diseases involving ocular surface: Steven-Johnson syndrome, Sjogren syndrome, chemical damage, limbal stem cell deficiency, corneal dystrophies, neoplasm of conjunctiva and cornea, infectious keratoconjunctivitis, etc. 5. Contact lens wear
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| non-invasive tear breakup time baseline and 8 weeks seconds | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and adverse effects throughout the study number of events,lipid layer thickness baseline and 8 weeks nanometers,Ocular surface symptom baseline and 8 weeks Ocular Surface Disease Index score,meibomian gland dropout baseline and 8 weeks percentage of area,meibomian gland expressibility baseline and 8 weeks number of glands that can be expressed,meibum quality baseline and 8 weeks normal, cloudy, granular, inspissated, absent,presence of Demodex baseline and 8 weeks present or absent,corneal and conjunctival staining baseline and 8 weeks grade by Oxford scale,patient preference at 8 weeks type of eyelid cleanser or neither | — |
Countries
Thailand
Contacts
Public ContactWannit Charusirisawad
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed