Refractive error
Conditions
Interventions
Control group:Use the lubricating solution for contact lenses produced by Shanghai Weikang Optical Eye Company Limited
Experimental group:Use the lubricating solution for contact lenses produced by Shanghai Mogix Medical Technology Co., Ltd.
Sponsors
Eye & ENT hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 40 years old, any gender; 2. For the left and right eyes, the range of soft hydrophilic contact lens sphere power, converted according to the empirical apex diopter conversion table, is -1.00D to -8.00D (inclusive). If astigmatism is present, the cylinder power should be =3:1. Note 1: For clinical convenience, the researcher uniformly sets the inclusion according to the least favorable principle (sphere-to-cylinder ratio >=3:1). 3. The best-corrected visual acuity for both left and right eyes with glasses is >=5.0 Note 2 (equivalent to a decimal visual acuity of 1.0); Note 2: Here and below, a visual acuity of 5.0 refers to the standard LogMAR chart. Clinically, try to use the standard LogMAR chart, and if it's not available, researchers should follow the procedures in Appendix 4. 4. Able to understand the purpose of the trial, willing to participate, and able to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Current systemic diseases that may affect the eyes, such as Sjögren's syndrome, diabetes, Down syndrome, hyperthyroidism, rheumatoid arthritis, mental disorders, or diseases that have occurred within the past year and include sinusitis or other conditions that the researchers consider unsuitable for wearing contact lenses; 2.Existing corneal abnormalities (such as those who plan to undergo or have undergone corneal surgery during the trial, have a history of corneal trauma, or have reduced corneal sensation, etc.), or active corneal infections (such as bacterial, fungal or viral corneal infections, etc.); 3.Any eye inflammation, cornea, conjunctiva or eyelid disorders, injuries or structural abnormalities affecting the wearing of contact lenses (such as dacryocystitis, glaucoma, etc.), or fundus abnormalities that the researchers consider affecting the wearing of contact lenses; 4.Other clinically significant findings from slit lamp examination; 5.Currently using drugs that may affect the trial product, cause dry eyes, affect vision and corneal curvature or alter normal ocular physiology, or drugs that the researchers determine may affect the wearing of contact lenses; 6.Those who have been in a special working or living environment for a long time, such as exposure to dispersed dust, pharmaceuticals, aerosols (such as hair gel, volatile chemicals), dust, etc., which affect the wearing of contact lenses; 7.Abnormal intraocular pressure (intraocular pressure 21 mmHg, or a difference of >= 5 mmHg between the two eyes); 8.Tear film rupture time <= 5 seconds; 9.Evaluation of corneal endothelial polymorphic changes as grade 4; 10.Those who have worn corneal reshaping hard oxygen-permeable contact lenses within 30 days before screening; 11.Those who have participated in drug clinical trials within 3 months before screening or within 1 month before participating in medical device clinical trials; 12.Those with contact lens and/or lens care product allergies; 13.Those who cannot use contact lenses, lubricating solutions for contact lenses, or cannot undergo regular eye examinations as required; 14.Pregnant women, lactating women, or those planning to become pregnant; 15.Other situations that the researchers determine make the study participants unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The comfort levels of the left and right eyes of the experimental group and the control group after wearing glasses for 30 days;The best corrected visual acuity of the left and right eyes wearing contact lenses for 30 days in the experimental group and the control group; | — |
Secondary
| Measure | Time frame |
|---|---|
| The best corrected visual acuity of the left and right eyes wearing contact lenses on the day of wearing them, and after 7 days and 90 days of wearing them.;The comfort levels of the left and right eyes on the day of wearing the glasses, and after 7 days and 90 days of wearing them; | — |
Countries
China
Contacts
Public ContactChen Zhi
Eye & ENT hospital of Fudan University
Outcome results
None listed