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

NCT06616480 | Completed

• 1 other identifier: DSFNC1 202303
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Efficacy evaluation indexes

  The proportion of contact lens-corrected eyesight, The percentage of changes in iris color

  after wearing lenses for 7 days

Secondary Outcomes (3)

• Time of Break up time (BUT)

  on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days

• Distance Uncorrected visual acuity (UCVA)

  on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days

• Fitness of the contact

  on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days

Other Outcomes (1)

• Efficacy evaluation indexes

  on the day of wearing the lens and after wearing lenses for 30 days and 90 days

Study Arms (2)

BenQ Materials DSFNC1 lenses

EXPERIMENTAL

BenQ Materials contact lens wears for daily disposable

Device: BenQ Materials DSFNC1 soft hydrophilic contact lenses

Visco SiHy Color lens

ACTIVE COMPARATOR

Device: Visco SiHy Color soft hydrophilic contact lenses

Interventions

BenQ Materials DSFNC1 soft hydrophilic contact lenses DEVICE

Test lenses were to be worn for approximately 90 days.

BenQ Materials DSFNC1 lenses

Visco SiHy Color soft hydrophilic contact lenses DEVICE

Control lenses were to be worn for approximately 90 days

Visco SiHy Color lens

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old, gender is not limited;
• Soft hydrophilic contact lenses to be worn range from 0.00 to -12.00D;
• Both eyes were normal with no other abnormality or disease other than refractive error;
• Best-corrected eyesight ≥ 1.0 in both eyes with frame lenses;
• Astigmatism ≤ 2.0D;
• T5ar film break-up time (BUT) \>5s in both eyes
• 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;
• 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.

You may not qualify if:

• 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;
• Those who had worn hard contact lenses within 4 weeks or soft contact lenses within 7 days prior to enrollment in this trial;
• People who are allergic to contact lens, and people with systemic allergic diseases;
• Patients with conical corneas or other irregular corneas;
• 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;
• Those who are pregnant, breastfeeding, or planning a pregnancy at the time of enrollment;
• Those who were eligible for enrollment in only one eye;
• 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
• 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;
• Other conditions that, in the judgment of the investigator, make wearing soft contact lenses unsuitable or preclude enrollment.

Sponsors & Collaborators

• BenQ Materials Corporation: lead

Study Sites (1)

BenQ Materials Corporation

Taoyuan, 33341, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 27, 2024
• Study Start: March 3, 2023
• Primary Completion: March 28, 2024
• Study Completion: June 20, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)