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

BenQ Materials Corporation

Status: Completed

Conditions: Myopia

Treatments: Device: Visco Oxypure Color soft hydrophilic contact lenses; Device: BenQ Materials MSENCI soft hydrophilic contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT06616519

MSENC1 202101

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

BenQ Materials MSENCI lenses

Experimental group

Description:

BenQ Materials Daily disposable contact lens wears for 1 month

Treatment:

Device: BenQ Materials MSENCI soft hydrophilic contact lenses

Visco Oxypure lens

Active Comparator group

Treatment:

Device: Visco Oxypure Color soft hydrophilic contact lenses