A Study to Evaluate the Safety and Efficacy of DSFNC1 Soft Hydrophilic Contact Lenses and SiHy Color Soft Hydrophilic Contact Lenses

BenQ Materials Corporation

Status: Completed

Conditions: Myopia

Treatments: Device: Visco SiHy Color soft hydrophilic contact lenses; Device: BenQ Materials DSFNC1 soft hydrophilic contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT06616480

DSFNC1 202303

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

192 participants in 2 patient groups

BenQ Materials DSFNC1 lenses

Experimental group

Description:

BenQ Materials contact lens wears for daily disposable

Treatment:

Device: BenQ Materials DSFNC1 soft hydrophilic contact lenses

Visco SiHy Color lens

Active Comparator group

Treatment:

Device: Visco SiHy Color soft hydrophilic contact lenses