Relieve dryness and discomfort in the eyes caused by wearing contact lenses
Conditions
Interventions
Experimental group:Adopt our company's developed product (recombinant collagen protein lubricating solution for contact lenses)
Control group:Adopt products from other companies (such as lubricating solution for contact lenses)
Sponsors
Wenzhou Medical University Affiliated Eye and Vision Hospital
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 8 years old and above, gender not limited; 2. The degree of the hard contact lenses that need to be worn is between -1.00D and -6.00D (including -1.00D and -6.00D); Column diopter, regular astigmatism=5.0 (decimal corresponds to 1.0); 5. Voluntarily participate in this clinical trial and sign the informed consent form for the subjects.
Exclusion criteria
Exclusion criteria: 1. Those who have worn orthokeratology lenses within the past month; 2. Those who suffer from systemic diseases that cause low immunity or affect corneal shaping (such as diabetes, Down's syndrome, rheumatoid arthritis, etc.; acute and chronic sinusitis within one year); 3. Corneal abnormalities: Have undergone corneal surgery before, or plan to undergo corneal refractive surgery in the near future, or have a history of corneal trauma; Patients with active keratitis (such as corneal infection, etc.) and decreased corneal sensitivity; Individuals with a history of eye trauma or intraocular surgery; Patients with retinal lesions and other organic eye diseases; 4. Individuals with the following eye conditions: 1) Eye abnormalities or infections within the first 30 days of screening; 2) Any eye disease, injury or structural abnormality that affects the cornea, conjunctiva or eyelids, such as dacryocystitis, acute conjunctivitis, blepharitis and other inflammations, glaucoma, etc; 3) Dry eye syndrome (tear film rupture time (BUT)21mmHg or binocular intraocular pressure difference>5mmHg); 7. Corneal endothelial cell density<2000 cells/mm ^ 2; 8. Patients who are currently using or need to use drugs that may cause dry eye or affect vision and corneal curvature (atropine, immunosuppressants, glucocorticoids, antibiotics, intraocular pressure lowering drugs, etc.) within the past month or during the research period; 9. Individuals with a history of allergies to contact lenses or contact lens care products; 10. The examination results indicate other contraindications for wearing orthokeratology lenses (such as obvious fluorescent staining of corneal epithelium) or patients who are not suitable for wearing orthokeratology lenses; 11. Pregnant or lactating women, and those with pregnancy plans during the trial period; 12. Screening individuals who have participated in clinical trials of other drugs within the past 3 months or clinical trials of other medical devices within the past 30 days; 13. Other situations where the subject meets the inclusion criteria for monocular examination or is deemed unsuitable for inclusion by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of best corrected visual acuity achieved by contact lenses;The comfort level of both eyes after wearing glasses; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual performance;Diopter;Contact lens fitting state;Observation of lubricating fluid and lens condition;Self-perceived symptom score;Fluorescence staining assessment; | — |
Countries
China
Contacts
Public ContactJiang Jun
Wenzhou Medical University Affiliated Eye and Vision Hospital
Outcome results
None listed