Ametropia
Conditions
Interventions
Test group:Use contact lens moisturizer
Control group:Use contact lens lubricant
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.18= age =40 years old, gender no limit; 2. The bulb degree of soft hydrophilic contact lens should range from -1.00D (inclusive) to -10.00D (inclusive); 3. If the astigmatism degree of main sense optometry is less than or equal to 1.50D, then the spherical lens degree: column lens degree =3:1; 4. The best corrected visual acuity of left and right main sense optometry is greater than or equal to 5.0 note 1 (equivalent to 1.0 decimal visual acuity); Note 1: The visual acuity of 5.0 here and below refers to the visual acuity of the standard logarithmic acuity chart. In clinical practice, the standard logarithmic acuity chart should be used as far as possible. If there is no standard logarithmic acuity chart, the investigator should follow the procedure agreed in Appendix 4. 5. 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 are considered unsuitable for wearing contact lenses within 1 year before signing the informed consent; 2. Use any topical ophthalmic or systemic medications that may interfere with the fitting of the contact lens/require the lens to be removed during the day. Common drugs that affect vision include tricyclic depressants, phenothiazines, general anesthetics, immunomodulators, etc. 3. 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 conjunctiva, etc.), glaucoma, corneal paresthesia, corneal epithelial defect, corneal endothelial cell depletion, cataract, keratoconus and irregular cornea, etc., should not be worn by researchers. 4. Dry eye injection 2 within 1 month before signing the informed consent or using the drug intervention, and the eye condition of the subject has been determined by the researcher, 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 glucocorticoid, immunosuppressant and so on. 5. Patients with a history of eye trauma or corneal surgery that affects the wearing of contact lenses; 6. Rupture time of tear film is less than or equal to 5s; 7. Abnormal intraocular pressure (intraocular pressure 21mmHg or binocular pressure difference > 5mmHg); 8. In any case where the researcher determines that the soft hydrophilic contact lens is not suitable for wearing, note 3; Note 3: In this clinical trial, the unsuitable conditions for wearing soft hydrophilic contact lenses are: (1) Eyelid abnormalities or infection; (2) Clinically significant slit-lamp findings (see Appendix 3 for details); (3) There are other active eye diseases. 9. The results of fundus examination do not meet the requirements of Appendix 3; 10. The results of corneal endothelial examination did not meet the requirements of Appendix 3; 11. Allergic patients who have used contact lenses, contact lens care products and/or fluorescein sodium stain strips; 12. People who wear soft hydrophilic contact lenses in special working or living environments such as dispersed dust, drugs, aerosol (such as hair spray, volatile chemicals) and dust for a long time; 13. Pregnant, lactating or planning to become pregnant at the time of inclusion; 14. Only one eye meets the entry criteria; 15. Unable to use the contact lens as required or unable to 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 other clinical trials (including rigid breathable contact lenses for orthokeratology) or concurrently participated in other clinical trials within 1 month before signing the informed consent; 17. Participants who have participated in drug clinical trials within 3 months before signing informed consent; 18. The researchers determined that the candidates could not be selected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The visual acuity of the left and right eyes in the experimental group and the control group was =5.0 at 30 days after wearing glasses;The comfort level of the left and right eyes of the experimental group and the control group after 30 days of wearing glasses was less than level 2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity in left and right eyes with glasses at 7 and 90 days after lens initiation and wearing;Left and right eye comfort at 7 and 90 days after lens initiation and wearing;The left and right eyes were corrected with glasses for 7, 30, and 90 days after the glasses were worn; | — |
Countries
China
Contacts
Public ContactWei Ruihua
Tianjin Medical University Eye Hospital
Outcome results
None listed