Efficacy Comparison between New Tea Tree Oil Eyelid Cleanser and Commercial OcuSOFT Eyelid Cleanser in Treatment of Meibomian Gland Dysfunction: Randomized Controlled Paired-eye Trial

Phase 1

• Conditions: 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

• Registration Number: TCTR20210923007
• Lead Sponsor: Office of Research Affairs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-23
• Study Completion: 2022-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
non-invasive tear breakup time baseline and 8 weeks seconds

Secondary Outcome Measures

Name	Time	Method
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