Refractive error
Conditions
Interventions
Control group :Moisturizing Blink contact lens lubricant
Investigational group:MeniconFIT II. contact lens lubricant
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 8 years (inclusive) at screening, any sex. 2.Best-corrected visual acuity in both eyes with spectacles >= 1.0 (decimal notation). 3.Willing to be randomized to either the investigational or control contact-lens lubricating solution per protocol, able to wear rigid contact lenses and use the assigned lubricating solution as directed, and able to attend all visits and complete the 3-month follow-up. 4.Both the subject and their parent(s) or legal guardian can understand and are willing to comply with the clinical-trial requirements and have provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Only the monocular meets the selection criteria; 2 Subjects and/or their guardians who are unable to understand the lens care process or use the nursing solution correctly; 3. Subjects who have been stably using rigid gas permeable contact lenses (RGP) or orthokeratology lenses (OK lenses) for less than 3 months; 4Subjects who may change lenses during the trial, or have abnormal lens condition during the screening period, abnormal lens condition is defined as any of the following: • Localized dry spots (not wet) on the front surface of the lenses; • Lenses are damaged; • Lenses with 2 or more scratches, or a single scratch affecting the base arc area (OK lens) / anterior and posterior surface optical zone (RGP); • Non-removable precipitate on the front surface of the lens; • 3 or more non-removable sediments on the back surface of the lens; 5. Have a history of allergy to rigid corneal contact lenses, rigid contact lenses lubricating fluid, or allergy to experimental medical devices; 6. Previous corneal diseases of any type, such as irregular cornea and keratoconus; Active keratitis (corneal infection, etc.), herpetic keratitis, corneal hyposensia, etc.; 7. Subjects in the screening period have ocular and ocular appendage diseases: such as dacryocystitis, conjunctivitis, blepharitis, etc.; 8. Patients with abnormal intraocular pressure (normal intraocular pressure range of 10~21 mmHg and intraocular pressure difference of less than 5 mmHg) or have received intraocular pressure lowering therapy within 3 months before screening; 9. Combined with strabismus and irregular astigmatism; 10 Ocular trauma in any eye within 3 months prior to screening, history of any type of corneal trauma, including but not limited to anterior segment contusion, posterior segment contusion, open eye penetration injury, intraocular foreign body, optic nerve contusion, ocular chemical burns, etc., as well as ocular appendage injury that may affect the results of the clinical trial as judged by the investigator; 11 Patients with pathological dry eye, tear film break-up time (BUT) = grade 2; 14. Systemic diseases (such as diabetes, hydrocephalus, Down syndrome, Marfan syndrome, rheumatoid arthritis, albinism, Behçet's syndrome, hyperthyroidism, etc.) that affect the wearing of contact lenses (such as acute and chronic sinusitis, mental illness, etc.), or diseases that affect the wearing of contact lenses (such as acute and chronic sinusitis, mental illness, etc.); 15. Those who are using or plan to use drugs that may cause dry eyes or affect vision or corneal curvature (such as atropine, hormonal eye drops, growth hormone, etc.) during the trial, or stop using the above drugs for less than 5 drug half-lives during the screening period; 16 Previous or planned corneal or intraocular surgery (including any type of refractive surgery) during the study, as well as ocular appendage surgery that may affect the results of the clinical study as judged by the investigator; 17. Suffer from other local or systemic diseases that are not suitable for wearing rigid contact lenses; 18. Pregnant, lactating or planning to become pregnant during the screening period or during the trial; 19. Those who are participating in other drug or medical device trials within 30 days before screening; 20. Other conditions judged by the investigator to be unsuitable for inclus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comfort grading ;Refraction ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best-corrected visual acuity with contact lenses; | — |
Countries
China
Contacts
Public ContactJiang Jun
Eye Hospital, Wenzhou Medical University
Outcome results
None listed