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A randomized, control clinical trial for the protection of Eyesucom to the ocular epithelium of the patient wearing orthokeratology lens

A randomized, control clinical trial for the protection of Eyesucom to the ocular epithelium of the patient wearing orthokeratology lens

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038279
Enrollment
Unknown
Registered
2020-09-15
Start date
2019-07-01
Completion date
Unknown
Last updated
2020-12-14

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

Conditions

Corneal epithelium injury

Interventions

test group:Eyesucom contact lens lubricant eye drops
control group:Boston rewetting drops

Sponsors

Zhongshan Opthalmic Center, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 8 to 65 years; 2. The patient has been prescribed appropriate overnight orthokeratology when enrolling time; 3. The corneal fluorescein staining was positive of any eye which after wearing orthokeratology; 4. The patient has not dry eye or any other ocular surface disease; 5. The patient has not any cornea refractive surgical history; 6. The patient can understand the objectives of the clinical trial, participate voluntarily and will sign the informed consent form by himself or by his/her legal guardian, and will complete the follow-up on time.

Exclusion criteria

Exclusion criteria: 1. The patient's adaptability for orthokeratology is bad, so the patient need to change the lens or stop wearing the lens under the jugement by investigator; 2. The patient with any abnomality as corneal ulcer, conjunctivitis, scleritis, uveitis, and other infective or non-infective eye disease; 3. The patient with any ocular trauma, ocular oncology, glaucoma, cataract, ocular fundus disease and other eye disease needing further treatment;; 4. The patient with serious or unstable disease in heart, liver, kidney, lung, internal secretion (including thyroid dysfunction) blood, mind dysfunction, or neurological dysfunction, etc; 5. The patient with diabetes mellitus; 6. Pregnant women or lactating women, or has pregnancy plan in the near future; 7. Not suitable of inclusion in other situation by the judgement of investigator.

Design outcomes

Primary

MeasureTime frame
Corneal fluorescein staining score;

Secondary

MeasureTime frame
Tear film break up time;subjective symptoms score;

Countries

China

Contacts

Public ContactJinling Yang

Shanghai Qisheng Medical Technology Development Co., Ltd.

yangjinling@3healthcare.com+86 21-62260793

Outcome results

None listed

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