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

NCT ID: NCT06616480

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-03
• Study Completion Date: 2024-06-20

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.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BenQ Materials DSFNC1 lenses

BenQ Materials contact lens wears for daily disposable

Group Type: EXPERIMENTAL

BenQ Materials DSFNC1 soft hydrophilic contact lenses

Intervention Type: DEVICE

Test lenses were to be worn for approximately 90 days.

Visco SiHy Color lens

Group Type: ACTIVE_COMPARATOR

Visco SiHy Color soft hydrophilic contact lenses

Intervention Type: DEVICE

Control lenses were to be worn for approximately 90 days

Interventions

BenQ Materials DSFNC1 soft hydrophilic contact lenses

Test lenses were to be worn for approximately 90 days.

Intervention Type: DEVICE

Visco SiHy Color soft hydrophilic contact lenses

Control lenses were to be worn for approximately 90 days

Intervention Type: DEVICE

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) >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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BenQ Materials Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BenQ Materials Corporation

Taoyuan, , China

Countries

China

Other Identifiers

DSFNC1 202303

Identifier Type: -

Identifier Source: org_study_id