None
Conditions
Interventions
Trial group:The trial group used the experimental contact lens lubricant (Shenyang Contec Medical Technology Co., Ltd., recommended usage: normally three times a day, one drop in each eye per time) an
Control group:The control group used the control lubricating eye drops for contact lenses (HYCOSAN Plus, recommended use: normally 3 times a day, 1 drop per eye each time), with follow-ups on the day
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years, any gender; 2. Myopia in both eyes not exceeding -8.00D, astigmatism not exceeding 1.00D, with a sphere-to-cylinder ratio of not less than 3:1; 3. Best-corrected vision with frame glasses in both eyes measured using the standard logarithmic visual acuity chart five-point recording method must be no less than 5.0; 4. Ability to understand the purpose of the study, voluntarily participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Wore rigid gas-permeable contact lenses for orthokeratology within 30 days prior to signing the informed consent form; 2. Had acute eye inflammation or eye trauma in either eye within 30 days prior to signing the informed consent form; 3. Currently suffering from any of the following diseases: Eye diseases: such as acute/chronic keratitis, conjunctivitis, glaucoma, irregular cornea, keratoconus, manifest strabismus, cataract, etc.; Systemic diseases that may affect the eyes, such as diabetes, hyperthyroidism, lupus, rheumatoid arthritis, etc.; 4. Previously underwent any refractive or corneal surgery in either eye; 5. Currently using any topical ophthalmic or systemic medications that may cause dry eye or affect vision (see Appendix 1); 6. Tear breakup time 21 mmHg or =5 mmHg during screening; 9. Allergic to components of contact lenses or trial lens lubricants, or have experienced severe adverse reactions when wearing contact lenses; 10. Unable to cooperate with physicians to complete examinations, such as due to mental or neurological disorders, intellectual disabilities, or psychological disorders; 11. Living or working environments unsuitable for wearing soft contact lenses, such as exposure to airborne dust, chemicals, aerosols (e.g., hairspray, volatile chemicals), dust, etc.; 12. Unable to wear soft contact lenses as required; 13. Pregnant, breastfeeding women, or women of childbearing age planning to become pregnant during the study; 14. Participated in a drug clinical trial within 90 days or a medical device clinical trial within 30 days prior to enrollment; 15. Corneal fluorescein staining > grade 2 during screening; 16. Fundus examinations during screening revealing abnormalities such as retinal tear, retinal detachment, or macular lesions; 17. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
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;Proportion of subjects whose best-corrected visual acuity with contact lenses in both the left and right eyes is >=5.0 seven days after wearing the lenses; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with a comfort rating of >=3 for both eyes at 7 and 90 days after wearing lenses, indicating a subjectively acceptable level;The proportion of subjects whose best corrected vision with contact lenses in the left and right eyes is >=5.0 at 30 and 90 days after wearing the lenses;Best-corrected visual acuity with contact lenses at 7, 30, and 90 days after wearing the lenses, and changes compared to baseline;Contact lens-corrected visual acuity of subjects at 7, 30, and 90 days after lens wear, and the change from baseline;Unaided visual acuity of subjects 90 days after wearing glasses and the changes from baseline;Best-corrected visual acuity after 90 days of wearing lenses and the change from baseline;Refractive power measured by subjective refraction after 90 days of wearing lenses and the change compared to baseline;Slit-lamp examinations of subjects on the day of lens wearing, and 7, 30, and 90 days after lens wearing;Tear film and corneal fluorescein staining examinations 7, 30, and 90 days after lens wearing;Corneal endothelial cell examinations, intraocular pressure measurements, and fundus examinations 30 and 90 days after lens ;Subjects' subjective acceptability on the day of wearing the lenses, and after 7, 30, and 90 days of wearing: comfort, vision, and ease of handling;Contact lens fitting status on the day of wearing lenses, and after 7 days, 30 days, and 90 days: central positioning, coverage, tightness, and mobility;The condition of the lenses on the day of wearing, and after 7, 30, and 90 days of use: whether the lenses have sediment, deformation, discoloration, rust spots, scratches, or damage;The condition of the lubricant on the day of wearing the lenses, and 7 days, 30 days, and 90 days after wearing: whether the product packaging is intact, whether the appearance is good, and whether the physical properties are normal (no cloudiness, impurities, or sediment); | — |
Countries
China
Contacts
Public ContactJun Jiang
Eye Hospital, Wenzhou Medical University
Outcome results
None listed