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A prospective, multicenter, randomized, open, parallel positive controlled clinical study to evaluate the efficacy and safety of multi-functional nursing solution for rigid gas permeable contact lens wearers

A prospective, multicenter, randomized, open, parallel positive controlled clinical study to evaluate the efficacy and safety of multi-functional nursing solution for rigid gas permeable contact lens wearers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066298
Enrollment
Unknown
Registered
2022-11-30
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Rigid contact lens wearer

Interventions

Experimental group:Rigid contact lens multifunctional care solution
Control group:Multifunctional care solution for rigid breathable contact lenses

Sponsors

Eye Hospital Affiliated to Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Age 8 or above; 2) The power of binocular lens is within -5.00D (including -5.00D), the power of cylindrical lens is within 1.50D, and the best corrected visual acuity >= of primary refraction is 5.0; 3) Able and willing to comply with all treatments and follow-up; 4) Be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form by the subject himself or his legal guardian

Exclusion criteria

Exclusion criteria: 1) Monocular meets the selection criteria; 2) Have systemic diseases that may affect the eyes, such as diabetes, Down syndrome, hyperthyroidism, rheumatoid arthritis, history of sinusitis within 2 years, or other diseases that the investigators believe cannot wear hard contact lenses; 3) Suffer from certain eye diseases that affect the wearing of hard contact lenses: such as acute or chronic eye diseases, spring catarrhal conjunctivitis, glaucoma, dry eye (BUT<5s), corneal abnormalities, etc.; 4) Patients with a history of allergy to contact lenses or contact lens care solutions; 5) Patients who are using or using drugs (immunosuppressants, glucocorticoids, ocular pressure lowering drugs, low-concentration atropine) that may cause dry eyes or affect vision and corneal curvature during the study; 6) Those who have a history of inner eye surgery; 7) Patients with abnormal intraocular pressure (normal intraocular pressure range is 10~21mmHg, and the difference in intraocular pressure between the two eyes should be <=5mmHg); 8) Those who participated in clinical trials of other drugs within 90 days before screening, and participated in clinical trials of other medical devices within 30 days; 9) Those who are pregnant, lactating or planning to become pregnant at the time of enrollment; 10) Those who cannot follow up as directed by the doctor; 11) Patients whose examination results indicate contraindications to wearing or who are not suitable for wearing hard contact lenses; 12) Other conditions in which the investigator determines that the patient is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
BCVA with contact lens;Sediment on the front surface of the lens;Sediment on the back surface of the lens;

Countries

China

Contacts

Public ContactJun Jiang

Eye Hospital Affiliated to Wenzhou Medical University

jjhsj@hotmail.com13506511080

Outcome results

None listed

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