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Evaluation of the Efficacy of 0.05% Ciclosporin Eye Drops in Dry Eye Patients Wearing Orthokeratology Lenses

A Comparative Efficacy Study on the Combined Application of 0.05% Ciclosporin Eye Drops and Sodium Hyaluronate Eye Drops in Dry Eye Patients with Orthokeratology Lens Wear Versus the Sole Application of Sodium Hyaluronate Eye Drops

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096102
Enrollment
Unknown
Registered
2025-01-17
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Dye Eye

Interventions

The test group:Combined use of Zirun ? (0.05% cyclosporine eye drops II) and Aiermin ? (0.1% sodium hyaluronate eye drops)
The control group:Ailmin ? alone (0.1% sodium hyaluronate eye drops)

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age 10-18 years old; 2. Myopia patients wearing orthokeratology lenses; 3. Complaining of one or more of the subjective symptoms such as eye dryness, foreign body sensation, burning sensation, fatigue, discomfort, eye redness, and vision fluctuations; 4. Fluorescein stained tear film break-up time (FBUT) <=5s; 5. Subjects and their legal guardians can understand the purpose of this trial, are willing to cooperate with treatment and follow-up, voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Eyelid entropion, ectropion, trichiasis, corneal ulcer, trachoma, keratitis, blepharitis/meibomian adenitis, meibonanitis/meibomian cyst, ocular trauma, lesions caused by corneal foreign bodies, burns, dacryocystitis and other infections, etc.; 2. Patients with abnormal intraocular pressure (normal intraocular pressure range is 10~21 mmHg, and the difference in intraocular pressure between the two eyes should be <=5 mmHg); 3. Those who are allergic to the use of drugs; 4. Patients with severe primary diseases and mental disorders such as liver, kidney and hematopoietic system; 5. Those who participate in other clinical validators or those who are considered inappropriate by the investigator to participate in this trial; 6. Those who are unable to follow up on time and do not sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
The fluorescein tear breakup time at 3 month;

Secondary

MeasureTime frame
Tear meniscus height;The fluorescein tear breakup time at 1 month;Schirmer I test;Corneal fluorescein staining test;Lissamine green staining test;Ocular redness index;Ocular Surface Disease Index (OSDI) score;Slit lamp test;Intraocular pressure;Visual acuity;Subjective refraction;

Countries

China

Contacts

Public ContactGe Wu

Eye Hospital, Wenzhou Medical University

wg_wmu@163.com+86 577 88068821

Outcome results

None listed

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