Ametropia
Conditions
Interventions
experimental group:Precision 1 lenses worn in each eye for up to 3 months.
control group:DAILIES Total 1 lenses worn in each eye for up to 3 months.
Sponsors
Eye Optometry Hospital Affiliated to Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subjects must be able to understand and sign the informed consent approved by the Ethics Committee; 2. Participants who are willing and able to participate in all pre arranged study visits in accordance with the program requirements; 3. Objects aged 18 and above; 4. Within one month (30 days) before the screening visit, the subjects who have successfully worn soft contact lenses for binocular far vision correction have voluntarily worn the soft contact lenses at least 5 days a week and 8 hours a day during the study period. 5. The diopter of each eye is not between -1.00d and -8.00d (including -1.00d, - 8.00d), and the astigmatism of each eye is <= 0.75D. 6. The best corrected far vision of each eye is better than or equal to 0.0 LogMAR.
Exclusion criteria
Exclusion criteria: 1. Women with reproductive potential, defined as all women who are physically able to conceive and are not postmenopausal for at least one year or less than six weeks after sterilization, shall be excluded if any of the following conditions are met: (1) Pregnancy; (2) Positive urine pregnancy test at screening; (3) Planned pregnancy during study; (4) Lactation. 2. Patients with irregular cornea, or anterior segment infection, inflammation or abnormality, or any disease (including systemic disease) that the researcher determines should not wear soft contact lenses; 3. Subjects who use systemic or eye drugs that may lead to contact lens wearing contraindications determined by researchers; 4. History of refractive surgery or patients who plan to have refractive surgery during the study period; 5. Patients who plan to perform corneal or intraocular surgery in the past 12 months or during the study period, and the ocular appendage surgery that may affect the clinical research results determined by the investigator; 6. According to the grading standard in the guiding principles for clinical trials of soft contact lenses, the results of biomicroscopy of baseline slit lamp were moderate or above and / or corneal neovascularization was mild or above; 7. The current or existing objects that may affect the wearing of contact lenses according to the judgment of researchers; 8. Patients with present or past history of herpetic keratitis; 9. Ocular trauma in any eye within three months before the trial, including but not limited to anterior segment contusion, posterior segment contusion, open perforating injury, intraocular foreign body, optic nerve contusion, chemical burn of the eye, and ocular appendage injury that may affect the clinical trial results determined by the researchers; 10. Patients who wear dt1 soft hydrophilic contact lens habitually; 11. Objects that are intolerant or allergic to soft contact lens products and their packaging solutions; 12. Staff of the research center or their families / family members listed in the list of researchers; 13. More than one person from the same family participated in the study; 14. Subjects who have participated in clinical trials or are currently participating in any other clinical trials within the past 30 days; 15. Patients with IOP > 21 mmHg, or with history or evidence of glaucoma, ocular hypertension or suspected glaucoma, or who had received any of the above treatments within 3 months prior to baseline / screening (visit 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CLCDVA: Contact lens corrected distance visual acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects who achieved CLCDVA in both eyes better than or equal to 0.0 logMAR; | — |
Countries
China
Contacts
Public ContactJia Qu
Eye Optometry Hospital Affiliated to Wenzhou Medical University
Outcome results
None listed