Myopia
Conditions
Brief summary
This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of MSENCI soft hydrophilic contact lenses with Oxypure color soft hydrophilic contact lenses used as the control product.
Interventions
DEVICEBenQ Materials MSENCI soft hydrophilic contact lenses
Test lenses were to be worn for approximately 90 days.
DEVICEVisco Oxypure Color soft hydrophilic contact lenses
Control lenses were to be worn for approximately 90 days
Sponsors
BenQ Materials Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old, no gender limitation; 2. Soft hydrophilic contact lenses worn should be from 0.00D to -12.00D; 3. Subjects should have normal binocular conditions without any abnormality or diseases except for ametropia; 4. The optimal binocular CVA with glasses ≥ 1.0; 5. The astigmatism should be ≤1.5D; 6. Binoculus BUT >5s; 7. should accept follow-ups for at least 90 days and wear the contact lens as required in the protocol; 8. should understand the purpose of the trial, volunteer to attend and sign the Informed Consent Form by the subjects themselves or their legal guardians. .
Exclusion criteria
1. Patients who suffer from systemic diseases that prohibit contact lens use or receive treatment that may affect the vision or contact lens use; 2. Patients who have worn hard contact lenses within 4 weeks or soft contact lenses within 7 days before being included in the trial; 3. Patients who are allergic to contact lenses or suffer from systemic allergy; 4. Patients who have keratoconus or other cornea irregularity; 5. Patients who always stay at places that are dry, dust-heavy, having volatile chemicals or otherwise affect the use of soft hydrophilic contact lenses; 6. People who are pregnant, during their lactation or prepare for the pregnancy while being included; 7. People who have only a single eye qualified for the trial; 8. People who have attended a clinical trial of medicine or medical devices other than contact lens within 3 months before being included in this trial; 9. People who have attended a clinical trial of medicine or medical devices other than contact lens within 3 months before being included in this trial; 10. Other cases where investigators determine the soft contact lens should not be used or the candidate should be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacy evaluation indexes | after wearing lenses for 7 days | Binocular CVA with lenses after wearing lenses, The percentage of changes in iris color |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of Break up time (BUT) | on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days | Comparison of BUT time results between the experimental group and control group |
| Distance Uncorrected visual acuity (UCVA) | on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days | Comparison of distance uncorrected visual acuity results between the experimental group and control group |
| Fitness of the contact | on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days | the position of lens on the ocular surface, the coverage, tightness and movability of lens |
Other
| Measure | Time frame | Description |
|---|---|---|
| efficacy evaluation indexes | on the day of wearing the lens and after wearing lenses for 30 days and 90 days | Instant iris color change after wearing lenses Binocular CVA with lenses ≥ 1.0 |
Countries
China
Outcome results
None listed