myopia or myopia with a certain amount of astigmatism
Conditions
Interventions
Control group:Wear soft hydrophilic contact lenses, Model RCH40, manufactured by Jilin Ruierkang Optics Technology Co., Ltd.
Test group:Wear soft hydrophilic contact lenses, Model TW41, manufactured by Chongqing Leiming Vision Technology Co., Ltd.
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 40 years inclusive, with no restriction on gender. 2.The spherical power of soft hydrophilic contact lenses for both left and right eyes converted via the empirical vertex power conversion table ranges from 0.00 D (inclusive) to -9.50 D (inclusive). If astigmatism is present, the astigmatic power shall not exceed 1.50 D, and the ratio of spherical power to cylindrical power shall be at least 3:1. 3.The best corrected visual acuity (BCVA) of both left and right eyes with spectacles is >=5.0. 4.Capable of understanding the trial objectives, willing to participate in this trial, and able to provide signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Subjects with active systemic diseases that may affect ocular conditions, such as Sjögren’s syndrome, diabetes mellitus, Down syndrome, hyperthyroidism, rheumatoid arthritis, psychiatric disorders, sinusitis, or other diseases deemed by the investigator to preclude contact lens wear. 2.Subjects with corneal abnormalities (including those who have undergone or plan to receive corneal surgery, with a history of corneal trauma, decreased corneal sensation, etc.) or active corneal infections (e.g., bacterial, fungal, or viral corneal infections). 3.Subjects with other active ocular inflammations judged by the investigator to interfere with contact lens wear. 4.Subjects with any corneal, conjunctival, or eyelid disorders, injuries or structural anomalies (such as dacryocystitis, glaucoma) or fundus abnormalities deemed by the investigator to affect contact lens wear. 5. Other clinically significant slit-lamp findings, including but not limited to significant slit-lamp findings listed in Table A1 of Appendix 3 to the protocol. 6.Subjects receiving medications that may interfere with the test product, induce dry eye, impair visual acuity, alter corneal curvature or disrupt normal ocular physiology, or medications judged by the investigator to affect contact lens wear. 7.Subjects who are chronically exposed to special working or living environments with airborne dust, pharmaceuticals, aerosols (e.g., hairspray, volatile chemicals) and other contaminants that hinder contact lens wear. 8. Subjects with abnormal intraocular pressure (IOP 21 mmHg, or an interocular IOP difference =5 mmHg). 9.Subjects with tear film breakup time (TFBUT) =5 seconds. 10.Subjects with grade 4 corneal endothelial polymegathism. 11.Subjects who wore rigid gas permeable orthokeratology contact lenses within 30 days prior to screening. 12.Subjects who participated in a soft hydrophilic contact lens clinical trial within 1 week prior to screening, other medical device clinical trials within 1 month prior to screening, or pharmaceutical clinical trials within 3 months prior to screening. 13.Subjects with allergies to contact lenses, contact lens care products, and/or fluorescein sodium test strips. 14.Subjects who are unable to wear the soft hydrophilic contact lenses as required or attend scheduled ocular examinations regularly. 15. Pregnant women, breastfeeding women, or women planning pregnancy. 16.Any other conditions for which the investigator determines the subject is ineligible for enrollment.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Corrected Visual Acuity with Contact Lenses for Right and Left Eyes;Outdoor Best Corrected Visual Acuity with Contact Lenses, Right Eye (OD) / Left Eye (OS);Best?corrected visual acuity of right and left eyes (spectacle correction; | — |
Primary
| Measure | Time frame |
|---|---|
| Corrected Visual Acuity with Contact Lenses for Right and Left Eyes; | — |
Countries
China
Contacts
Public ContactWei Ruihua
Tianjin Medical University Eye Hospital
Outcome results
None listed