A Comparative Study of the Effects of Different Types of Eyelid Cleansers on the Ocular Surface Microbiota and Disease Activity in Patients with Mild to Moderate Meibomian Gland Dysfunction: A Randomized Controlled Trial

Phase 3

• Conditions: A Comparative Study of the Effects of Different Types of Eyelid Cleansers on the Ocular Surface Microbiota and Disease Activity in Patients with Mild to Moderate Meibomian Gland Dysfunction: A Pilot Randomized Controlled Trial; Microbiota; Meibomian Gland Dysfunction; Eyelid Cleansers

• Registration Number: TCTR20240426005
• Lead Sponsor: Faculty of medicine Chiang Mail university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-26
• Last Update Posted: 19 August 2024
• Study Completion: 2025-01-03

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. Age >18 years old
2. Patient with mild to moderate MGD

Exclusion Criteria

1. Vernal or atopic keratoconjunctivitis
2. Rosacea
3. Altered eyelid anatomy, pterygium or trichiasis
4. Active ocular surface diseases other than mild to moderate MGD, such as keratitis and anterior blepharitis
5. Active orbital/ocular adnexal diseases such as dacryocystitis, nasolacrimal duct obstruction and thyroid eye disease.
6. Previous punctual occlusion or ocular/ocular adnexal surgery
7. History of ocular and adnexal injuries within 1 year
8. Contact lens use within six months
9. Anti-glaucoma, antibiotics, steroids, and cyclosporin or other immunosuppressive drugs within a month
10. Diabetes mellitus
11. Autoimmune diseases
12. Immunocompromised conditions such as human immunodeficiency virus infection and cancer on chemotherapy
13. Pregnancy or lactation
14. History of allergy to the components of shampoo and lid cleansing agents

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the profiles of ocular surface microbiota before and after treatment with lid cleansers 1 month DNA

Secondary Outcome Measures

Name	Time	Method
To compare the profiles of ocular surface microbiota after treatment between patients with mild to moderate MGD 1 month DNA,To compare the clinical score of MGD before and after treatment with lid cleansers in patients with mild to moderate MGD 1 month DNA,To compare the clinical score of after treatment with lid cleansers between patients with mild to moderate MGD 1 month DNA,To explore the association between diversity/abundance of microbiota and severity of MGD 1 month DNA