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

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

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: BenQ Materials DSFNC1 soft hydrophilic contact lenses; Device: Visco SiHy Color soft hydrophilic contact lenses

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Taoyuan, China, 33341
    • BenQ Materials Corporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BenQ Materials DSFNC1 lenses; BenQ Materials contact lens wears for daily disposable	Device: BenQ Materials DSFNC1 soft hydrophilic contact lenses; Test lenses were to be worn for approximately 90 days.
Active Comparator: Visco SiHy Color lens	Device: Visco SiHy Color soft hydrophilic contact lenses; Control lenses were to be worn for approximately 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy evaluation indexes	The proportion of contact lens-corrected eyesight, The percentage of changes in iris color	after wearing lenses for 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Break up time (BUT)	Comparison of BUT time results between the experimental group and control group	on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
Distance Uncorrected visual acuity (UCVA)	Comparison of distance uncorrected visual acuity results between the experimental group and control group	on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
Fitness of the contact	the position of lens on the ocular surface, the coverage, tightness and movability of len	on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy evaluation indexes	The percentage of iris color change after wearing lenses ,The proportion of contact lens corrected eyesight	on the day of wearing the lens and after wearing lenses for 30 days and 90 days

Collaborators and Investigators

• Sponsor: BenQ Materials Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2023
• Primary Completion (Actual): March 28, 2024
• Study Completion (Actual): June 20, 2024

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: DSFNC1 202303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No