A Study to Evaluate the Safety and Efficacy of MSENC1 Soft Hydrophilic Contact Lenses and Oxypure Color Soft Hydrophilic Contact Lenses

Multi-center, Open, Parallel, and Randomly Controlled Comparison Between MSENC1 Soft Hydrophilic Contact Lenses and Oxypure Color Soft Hydrophilic Contact Lenses in Their Safety and Efficacy

This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of MSENCI soft hydrophilic contact lenses with Oxypure color soft hydrophilic contact lenses used as the control product.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: BenQ Materials MSENCI soft hydrophilic contact lenses; Device: Visco Oxypure 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, no gender limitation;
2. Soft hydrophilic contact lenses worn should be from 0.00D to -12.00D;
3. Subjects should have normal binocular conditions without any abnormality or diseases except for ametropia;
4. The optimal binocular CVA with glasses ≥ 1.0;
5. The astigmatism should be ≤1.5D;
6. Binoculus BUT >5s;
7. should accept follow-ups for at least 90 days and wear the contact lens as required in the protocol;

8. should understand the purpose of the trial, volunteer to attend and sign the Informed Consent Form by the subjects themselves or their legal guardians.

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Exclusion Criteria:

1. Patients who suffer from systemic diseases that prohibit contact lens use or receive treatment that may affect the vision or contact lens use;
2. Patients who have worn hard contact lenses within 4 weeks or soft contact lenses within 7 days before being included in the trial;
3. Patients who are allergic to contact lenses or suffer from systemic allergy;
4. Patients who have keratoconus or other cornea irregularity;
5. Patients who always stay at places that are dry, dust-heavy, having volatile chemicals or otherwise affect the use of soft hydrophilic contact lenses;
6. People who are pregnant, during their lactation or prepare for the pregnancy while being included;
7. People who have only a single eye qualified for the trial;
8. People who have attended a clinical trial of medicine or medical devices other than contact lens within 3 months before being included in this trial;
9. People who have attended a clinical trial of medicine or medical devices other than contact lens within 3 months before being included in this trial;
10. Other cases where investigators determine the soft contact lens should not be used or the candidate should be excluded.

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 MSENCI lenses; BenQ Materials Daily disposable contact lens wears for 1 month	Device: BenQ Materials MSENCI soft hydrophilic contact lenses; Test lenses were to be worn for approximately 90 days.
Active Comparator: Visco Oxypure lens	Device: Visco Oxypure 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	Binocular CVA with lenses after wearing lenses, 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 lens	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	Instant iris color change after wearing lenses Binocular CVA with lenses ≥ 1.0	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): May 18, 2021
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): August 25, 2022

Study Registration Dates

• First Submitted: September 19, 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: MSENC1 202101

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
• product manufactured in and exported from the U.S.: No