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Adjunctive Use of Eyelid Wipes Improves Early Ocular Surface Adaptation in Pediatric Orthokeratology: A Randomized Controlled Trial

Clinical Study on the Effects of OCUFACE Eyelid Wipes on Ocular Surface Health in Pediatric Orthokeratology Wearers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115713
Enrollment
Unknown
Registered
2025-12-30
Start date
2025-08-02
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myopia

Interventions

eyelid-wipe group:In addition to routine orthokeratology (OK) lens wear and care, participants will use OCUFACE? eyelid-cleaning wipes once daily, before lens wear at night, for one month.
control group:Participants will receive only standard OK lens wear and care instructions, without the use of any additional eyelid-cleaning products.

Sponsors

Guangzhou Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Children and adolescents aged 8–12 years; 2. Spherical equivalent refractive error between –1.00 D and –6.00 D, with astigmatism = 1.50 D; 3. No significant dry eye–related symptoms; 4. No severe ocular surface or eyelid diseases (e.g., active blepharitis, keratoconjunctivitis, severe allergic conjunctivitis, etc.); 5. Suitable candidates for orthokeratology for refractive correction; 6. No regular use of other eyelid-cleaning products or anti-inflammatory medications (including corticosteroids, cyclosporine, tacrolimus, etc.) within the past 3 months; 7. The legal guardian of the participant provides informed consent, and the participant is willing to comply with follow-up visits and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Presence of severe corneal staining, corneal ulcer, keratoconus, or other significant corneal diseases; 2. History of ocular surgery or severe ocular trauma; 3. Presence of systemic diseases that may affect the tear film or ocular surface (e.g., Sjögren’s syndrome, rheumatoid arthritis, etc.); 4. Known allergy to any component of the eyelid-cleaning wipes; 5. Planned change of orthokeratology lens brand or care solution during the study period; 6. Participation in any other interventional clinical study within the past 3 months; 7. Poor compliance; 8. Any other condition that the investigator considers inappropriate for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
NITBUT;Change in eyelid margin cleanliness/secretion score;

Secondary

MeasureTime frame
Change in tear break-up time;Change in tear meniscus height;Lipid layer thickness;Meibomian gland expressibility;Meibomian gland dropout ratio;Oxford corneal staining score;MMP-9 inflammatory test results;Change in OSDI total score;Change in contact lens wearing comfort;

Countries

China

Contacts

Public ContactXiaoxiao Zhang

Guangzhou Aier Eye Hospital

xzhangc2677@163.com+86 137 6061 2001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026