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

NCT ID: NCT06616519

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-18
• Study Completion Date: 2022-08-25

Brief Summary

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.

Conditions

Myopia

Study Design

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

Study Groups

BenQ Materials MSENCI lenses

BenQ Materials Daily disposable contact lens wears for 1 month

Group Type: EXPERIMENTAL

BenQ Materials MSENCI soft hydrophilic contact lenses

Intervention Type: DEVICE

Test lenses were to be worn for approximately 90 days.

Visco Oxypure lens

Group Type: ACTIVE_COMPARATOR

Visco Oxypure Color soft hydrophilic contact lenses

Intervention Type: DEVICE

Control lenses were to be worn for approximately 90 days

Interventions

BenQ Materials MSENCI soft hydrophilic contact lenses

Test lenses were to be worn for approximately 90 days.

Intervention Type: DEVICE

Visco Oxypure 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, 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.

• 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

MSENC1 202101

Identifier Type: -

Identifier Source: org_study_id