None listed
Conditions
Interventions
Trial group:The trial group used the experimental contact lens lubricating solution (usage recommendation: normally use once before going to bed and once after waking up in the morning, with 1 drop p
Control group:The control group used the control contact lens lubricating solution (usage recommendation: normally use once before going to bed and once after waking up in the morning, with 1 drop per
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 8 years, any gender; 2. Myopia in both eyes between -1.00D and -4.00D (inclusive), with regular astigmatism not exceeding 1.75D and irregular astigmatism not exceeding 1.50D; 3. Best-corrected visual acuity in both eyes with spectacles, measured using the standard logarithmic visual acuity chart with the five-record method, must be no less than 5.0; 4. Able to understand the purpose of the trial, voluntarily participate, and provide informed consent signed by the participant or their legal guardian. Note: For minors aged over 8 but under 18, both the participant and their guardian must provide informed consent and sign the consent form. Adults aged 18 and above must provide informed consent and sign the consent form themselves.
Exclusion criteria
Exclusion criteria: 1. Wore rigid contact lenses (including orthokeratology lenses) within 30 days before signing the informed consent form; 2. Have systemic diseases causing immunodeficiency or affecting orthokeratology, such as diabetes, hyperthyroidism, lupus, Down syndrome, rheumatoid arthritis, acute/chronic sinusitis (within 1 year), etc.; 3. Eye conditions as follows: active corneal infection (bacterial, fungal, viral, etc.); acute, subacute, or chronic inflammation or infection of the anterior segment; any eye disorder, injury, or structural abnormality affecting the cornea, conjunctiva, or eyelids, such as dacryocystitis, acute conjunctivitis, blepharitis, various inflammations, glaucoma, etc.; pathological ocular congestion or redness; 4. Any eye with a history of corneal abnormalities, corneal surgery, corneal trauma, or decreased corneal sensation, judged by the investigator as unsuitable for wearing orthokeratology lenses; 5. Unstable refractive error (as determined by the investigator); 6. Irregular corneal astigmatism or manifest strabismus; 7. Currently using or planning to use during the study medications that may cause dry eye or affect vision (such as atropine; excluding mydriatic agents used before vision tests) or corneal curvature (immunosuppressants, glucocorticoids, intraocular pressure-lowering drugs, etc.); 8. During the screening period, intraocular pressure in either eye >21 mmHg or grade 2) or individuals not suitable for orthokeratology lens use; 12. Screening keratometry shows corneal flat curvature 46.00D; 13. Screening fundus examination reveals abnormalities such as retinal tears, retinal detachment, or macular lesions; 14. Allergic to contact lens or trial lens lubricants, protein removers, multipurpose solutions, or have experienced severe adverse reactions from wearing contact lenses; 15. Unable to cooperate with the doctor to complete examinations, such as those with psychiatric disorders, intellectual disabilities, or psychological disorders; 16. Unable to wear rigid contact lenses as required; 17. Pregnant women, breastfeeding women, or women of childbearing age planning to become pregnant during the study period; 18. Participated in a drug clinical trial within 90 days prior to enrollment or a medical device clinical trial within 30 days prior; 19. Other situations deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective acceptability of the left and right eyes 30 days after wearing the lenses—the proportion of subjects with comfort ratings of =3 for both eyes;The proportion of subjects whose best-corrected vision with contact lenses in both the left and right eyes is =5.0, 30 days after wearing the lenses; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a subjective acceptability level of =3 for comfort in the left and right eyes on day 1, day 7, and day 90 after wearing the lenses;The proportion of subjects whose best-corrected vision in the left and right eyes with contact lenses was =5.0 on day 1, day 7, and day 90 after wearing the lenses;The best-corrected visual acuity of subjects wearing contact lenses at 1 day, 7 days, 30 days, and 90 days, and the changes compared to baseline;Contact lens-corrected vision of subjects at 1 day, 7 days, 30 days, and 90 days after wearing the lenses, and the changes compared to baseline;The subjects' uncorrected visual acuity on day 1, day 7, day 30, and day 90 after wearing lenses, and the changes compared to baseline;Subjective refraction measurements and changes from baseline at 1 day, 7 days, 30 days, and 90 days after wearing the lenses;Corneal curvature and related key parameters reflected in corneal topography at 1 day, 7 days, 30 days, and 90 days after wearing lenses;Slit-lamp examinations and corneal fluorescein staining were performed on the subjects on the day of lens wear, and 1 day, 7 days, 30 days, and 90 days after lens wear;Tear film examinations at 1 day, 7 days, 30 days, and 90 days after wearing the lenses;Corneal thickness measurement, corneal endothelial cell examination, intraocular pressure measurement, and fundus examination at 30 and 90 days after wearing lenses;Subjects' subjective acceptability on the day of wearing the lenses, and after 1 day, 7 days, 30 days, and 90 days: comfort, vision, ease of handling, and lens cleanliness;Contact lens fitting status on the day of wearing, and 1 day, 7 days, 30 days, and 90 days after wearing: central positioning, tightness, movement, and fluorescein staining;Condition of the lenses on the day of wearing, and after 1 day, 7 days, 30 days, and 90 days: whether the lenses have any sediment, deformation, discoloration, rust spots, scratches, or damage;The condition of the lubricating | — |
Countries
China
Contacts
Public ContactJun Jiang
Eye Hospital, Wenzhou Medical University
Outcome results
None listed