Myopia
Conditions
Brief summary
This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of DSFNC1 soft hydrophilic contact lenses with SiHy color soft hydrophilic contact lenses.
Interventions
DEVICEBenQ Materials DSFNC1 soft hydrophilic contact lenses
Test lenses were to be worn for approximately 90 days.
DEVICEVisco SiHy 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, gender is not limited; 2. Soft hydrophilic contact lenses to be worn range from 0.00 to -12.00D; 3. Both eyes were normal with no other abnormality or disease other than refractive error; 4. Best-corrected eyesight ≥ 1.0 in both eyes with frame lenses; 5. Astigmatism ≤ 2.0D; 6. T5ar film break-up time (BUT) >5s in both eyes 7. Those who are able to complete a minimum of 90 days of follow-up and are able to wear contact lenses as required by the protocol; 8. Ability to understand the purpose of the trial, to participate voluntarily and to have Informed Consent signed by the subject himself/herself or his/her legal guardian.
Exclusion criteria
1. Persons with any systemic condition that contraindicates the wearing of contact lenses, or who are receiving treatment that interferes with vision or the wearing of contact lenses; 2. Those who had worn hard contact lenses within 4 weeks or soft contact lenses within 7 days prior to enrollment in this trial; 3. People who are allergic to contact lens, and people with systemic allergic diseases; 4. Patients with conical corneas or other irregular corneas; 5. Those who have to wear soft hydrophilic contact lenses for a long period of time under special circumstances such as dryness, severe dust or volatile chemicals; 6. Those who are pregnant, breastfeeding, or planning a pregnancy at the time of enrollment; 7. Those who were eligible for enrollment in only one eye; 8. Concurrent participation in other clinical trials or participation in a soft contact lens clinical trial of soft hydrophilic contact lenses within 10 days prior to enrollment in this trial 9. Participants who have participated in a clinical trial of a drug or a medical device other than a contact lens within 3 months prior to enrollment in this trial; 10. Other conditions that, in the judgment of the investigator, make wearing soft contact lenses unsuitable or preclude enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy evaluation indexes | after wearing lenses for 7 days | The proportion of contact lens-corrected eyesight, 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 len |
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 | The percentage of iris color change after wearing lenses ,The proportion of contact lens corrected eyesight |
Countries
China
Outcome results
None listed