Clinical trial NCT06616480: A Study to Evaluate the Safety and Efficacy of DSFNC1 Soft Hydrophilic Contact Lenses and SiHy Color Soft Hydrophilic Contact Lenses
Official title: Multicenter, Open, Parallel, Randomized Controlled Comparison on the Safety and Efficacy Clinical Study of DSFNC1 Soft Hydrophilic Contact Lenses With SiHy Color Soft Hydrophilic Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: BenQ Materials Corporation
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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) \&gt;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.

Primary outcomes:
measure: Efficacy evaluation indexes
timeFrame: after wearing lenses for 7 days
Secondary outcomes:
measure: Time of Break up time (BUT)
timeFrame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
measure: Distance Uncorrected visual acuity (UCVA)
timeFrame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
measure: Fitness of the contact
timeFrame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
Other outcomes:
measure: Efficacy evaluation indexes
timeFrame: on the day of wearing the lens and after wearing lenses for 30 days and 90 days
Locations:
city: Taoyuan
country: China
facility: BenQ Materials Corporation
Study officials:
References: