For the hydration treatment of soft contact lenses (including silicone hydrogel lenses), instilled into the eyes during lens wear to provide lubrication
Conditions
Interventions
Trial group:Adopting Contact Lens Lubricating Solution (Kangzhe) (Usage recommendation: 3~5 times daily, 1~2 drops per time). Follow-ups will be conducted on the day of lens wear, and at 7 days,30 da
Control group:Adopting Contact Lens Lubricating Solution (Hydron) (Usage recommendation:3~5 times daily, 1~2 drops per time). Follow-ups will be conducted on the day of lens wear, and at 7 days,30 da
Sponsors
Eye Hospital Affiliated to Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-65 years, both male and female ; 2.Myopia in both eyes not exceeding -8.00D, astigmatism not exceeding 1.50D,and spherical-to-cylindrical ratio no less than 3:1; 3.Best-corrected visual acuity with spectacles in both eyes measured by the standard logarithmic visual acuity chart (five-point recording method) is no less than5.0; 4.Able to understand the trial objectives, voluntarily participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Those who have worn rigid gas-permeable contact lenses for orthokeratology within 30 days prior to signing the informed consent form; 2.Presence of acute ocular inflammation or ocular trauma in either eye within 1 month prior to signing the informed consent form; 3.Currently suffering from the following diseases: (1)Ocular diseases: such as acute/chronic keratitis, conjunctivitis, glaucoma, irregular cornea, keratoconus, manifest strabismus, cataract, etc.; (2)Systemic diseases that may affect the eyes, such as diabetes, hyperthyroidism, lupus erythematosus, rheumatoid arthritis, etc.; 4.Previous refractive or corneal surgery in either eye; 5.Currently using any topical ophthalmic or systemic medications that may cause dry eye or affect vision; 6.Tear film breakup time =5s at screening; 7.Corneal endothelial cell density 21 mmHg or Grade 2 at screening; 16.Abnormal findings on fundus examination at screening, such as retinal holes, 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 |
|---|---|
| Proportion of subjects with subjective acceptability—comfort level >= Grade 3 in both left and right eyes ;Proportion of subjects with best-corrected visual acuity >= 5.0 in both left and right eyes ;Best-corrected visual acuity and changes from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with subjective acceptability score = grade 3 for comfort in both left and right eyes ;Proportion of subjects with contact lens best-corrected visual acuity = 5.0 in both left and right eyes ;Contact lens best-corrected visual acuity and changes from baseline ;Uncorrected visual acuity and changes from baseline ;Subjective refraction and changes from baseline ;Subjective acceptability (comfort, vision, handling) ;Contact lens fitting status : centration, coverage, tightness, and movement;State of lens condition:presence of deposits, deformation, discoloration, rust spots, scratches, or damage on the lens;State of lubricating fluid:whether the product packaging is intact, appearance is satisfactory, and physical properties (presence of discoloration, turbidity, or impurities);Contact lens corrected visual acuity and changes from baseline ;Ocular examinations: tear film evaluation, slit-lamp examination, corneal endothelial cell count, corneal fluorescein staining, intraocular pressure measurement, fundus examination; | — |
Countries
China
Contacts
Public ContactJiang Jun
Eye Hospital Affiliated to Wenzhou Medical University
Outcome results
None listed