Refractive error
Conditions
Interventions
Control group:Use the Contact Lens lubricant (Clear Contact Lens Eye Drops) produced by Xindong Biotech Co., LTD.
Experimental Group:Use the contact lens lubricant (model: Gene? EGT) produced by Jiangsu Zhisan Biotechnology Co., LTD.
Sponsors
Eye Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.18=3:1; 3. The best corrected visual acuity of the left and right glasses is >=5.0 Note 1 (equivalent to 1.0 of decimal visual acuity); Note 1: The visual acuity here and below is 5.0 refers to the visual acuity of the standard logarithmic visual acuity chart, and the standard logarithmic visual acuity chart is used as much as possible in clinical practice. 4. Able to understand the purpose of the trial, willing to participate in this trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Currently suffering from systemic diseases that may affect the eyes, such as Sjogren's syndrome, severe diabetes, Down syndrome, hyperthyroidism, rheumatoid arthritis, mental illness, or having sinusitis or other diseases that researchers consider unsuitable for wearing contact lenses within one year; 2. Existing corneal abnormalities (such as those planning to undergo corneal surgery during the trial period or having undergone corneal surgery before, having a history of corneal trauma, corneal hypocorneal sensation, etc.), or having active corneal infections (such as bacterial, fungal or viral corneal infections, etc.); 3. Any ocular inflammation, corneal, conjunctival or eyelid disease, injury or structural abnormality (such as dacryocystitis, glaucoma, etc.) that researchers believe will affect the wearing of contact lenses, or any fundus abnormality that researchers believe will affect the wearing of contact lenses; 4. Other clinically significant findings of slit lamp examination Note 2; Note 2: Including but not limited to the meaningful slit lamp examination findings in Appendix 3 of the plan. 5. Drugs that are currently in use and may affect the test product, causing dry eyes, affecting vision and corneal curvature or altering normal eye physiology, or drugs that the researcher has determined may affect the wearing of contact lenses; 6. Those who are exposed to special working or living environments such as dispersed dust, medicines, aerosols (such as hair spray, volatile chemicals), and dust for a long time, which may affect the wearing of contact lenses; 7. Abnormal intraocular pressure (intraocular pressure 21mmHg, or intraocular pressure difference between both eyes =5mmHg); 8. Those whose tear film break-up time is =5 seconds; 9. Those with corneal endothelial pleomorphic changes evaluated as grade 4; 10. Those who have worn rigid breathable contact lenses for orthokeratology within 30 days before screening; 11. Those who have participated in drug clinical trials within 3 months or medical device clinical trials within 1 month before screening; 12. People who have been allergic to contact lenses and/or care products; 13. Those who fail to use contact lenses, contact lens lubricating fluid as required or cannot have regular eye examinations; 14. Pregnant women, lactating women or those planning to become pregnant; 15. Other circumstances in which the researcher determines that the subject is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The best corrected visual acuity of the left and right eyes with contact lenses in the experimental group and the control group after wearing glasses for 30 days.;The comfort level of the left and right eyes of the experimental group and the control group after wearing glasses for 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| The best corrected visual acuity of the left and right eyes with contact lenses on the day of wearing the glasses, 7 days after wearing the glasses, and 90 days after wearing the glasses;Comfort of the left and right eyes on the day of wearing glasses, 7 days after wearing glasses, and 90 days after wearing glasses.; | — |
Countries
China
Contacts
Public ContactWei Ruihua
Eye Hospital of Tianjin Medical University
Outcome results
None listed