Ametropia
Conditions
Interventions
Test group:Wear soft hydrophilic contact lens (model: H55AMT, Specification: A)
Control group:Wear soft Brand Contact Lenses for 1 DAY ACUVUE MOIST Brand Contact Lenses for ASTIGMATISM
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.18= age =45 years old, gender is not limited; 2. The best corrected visual acuity of left and right eye is greater than or equal to 5.0 Note 1 (equivalent to 1.0 of decimal visual acuity); Note 1: The visual acuity of 5.0 here and below refers to the visual acuity of the standard logarithmic visual acuity chart. The standard logarithmic visual acuity chart is used as far as possible in clinical practice. If there is no standard logarithmic visual acuity chart, the investigator shall follow the procedure agreed in Appendix 4. 3. Able to understand the purpose of the trial, willing to participate in the clinical trial, and sign the informed consent
Exclusion criteria
Exclusion criteria: 1. Have a systemic disease that may affect the eyes, such as diabetes mellitus, Down syndrome, hyperthyroidism, rheumatoid arthritis, a history of sinusitis, or other diseases that the investigator deems unsuitable for wearing contact lenses within 1 year prior to signing the informed consent; 2. Simultaneous use of any topical ophthalmic or systemic medications that may interfere with contact lens fitting/require contact lens removal during the day. Common drugs that affect vision include tricyclic depressants, phenothiazines, general anesthetics, immunomodulators, etc. 3. Suffer from various eye diseases within 3 months before signing the informed consent, including but not limited to: Patients with acute or chronic ocular inflammation (chronic keratitis, chronic uveitis, chronic dacryocystitis, chronic blepharitis, iritis, seborrheic conjunctival, etc.), glaucoma, abnormal corneal perception, corneal epithelial defect, corneal endothelial depletion, cataract, keratoconus and irregular cornea, etc., should not be worn by researchers; 4. Dry eye infusions that are being used within 1 month before signing the informed consent or are planning to use drug intervention during the study period, and the eye condition of the subject is determined by the investigator and the contact lens is not suitable for wearing in combination with the recent drug use; Note 2: Drugs include drugs for dry eyes, such as artificial tears, calf serum extracts, non-steroidal anti-inflammatory drugs, etc. And the treatment of moderate and severe dry eye glucocorticoids, immunosuppressants and so on. 5. Previous history of eye trauma or corneal surgery affecting the wearing of contact lenses; 6. Tear film rupture time is less than or equal to 5s; 7. Abnormal intraocular pressure (IOP 21mmHg or binocular pressure difference > 5mmHg); 8. Any situation in which researchers have determined that soft hydrophilic contact lenses are not suitable for wearing note 3; Note 3: The conditions in which soft hydrophilic contact lenses are not suitable for use in this clinical trial are: (1) Eyelid abnormality or infection; (2) Clinically significant slit-lamp findings (see Appendix 3 for details); (3) There are other active eye diseases. 9. Fundus examination results are abnormal, and researchers believe that it is not suitable to wear contact lenses; 10. Corneal endothelial examination results did not meet the requirements of Appendix 3 of the protocol; 11. Allergic patients who have used contact lenses, contact lens care products and/or fluorescein sodium stain strips; 12. Long-term exposure to dispersive dust, drugs, aerosols (such as hair gel, volatile chemicals), dust and other special working or living environment affecting the wearing of soft hydrophilic contact lenses; 13. Pregnant, lactating or planning to become pregnant at the time of enrollment; 14. Only one eye meets the entry criteria; 15. Can not use the contact lens as required or can not carry out regular eye examination; 16. Participants who have participated in other soft hydrophilic contact lens clinical trials within 1 week before signing the informed consent, or who have worn rigid breathable contact lenses or participated in their clinical trials (including rigid breathable contact lenses for orthokeratology) within 1 month before signing the informed consent, or participated in other clinical trials at the same time; 17. Participants who have participated in drug clinical trials within 3 m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One week after wearing the contact lens, the corrected visual acuity of the left and right eyes was obtained; | — |
Secondary
| Measure | Time frame |
|---|---|
| Corrected visual acuity of the left and right eyes on the day of wearing the contact lens, 1 month and 3 months after wearing the contact lens;The best corrected visual acuity of the left and right eyes in the frame on the day of screening, lens wearing, and 3 months after lens wearing;Safety related indicators (eye condition, lens compatibility status, lens status, auxiliary equipment status, refractive status, subjective acceptability, incidence of adverse events, incidence of death events, incidence of device defects); | — |
Countries
China
Contacts
Public ContactLiu Ling
Tianjin Medical University Eye Hospital
Outcome results
None listed