Clinical trial NCT06616519: A Study to Evaluate the Safety and Efficacy of MSENC1 Soft Hydrophilic Contact Lenses and Oxypure Color Soft Hydrophilic Contact Lenses
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: BenQ Materials Corporation
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \&gt;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.

Primary outcomes:
measure: efficacy evaluation indexes
timeFrame: after wearing lenses for 7 days
Secondary outcomes:
measure: Time of Break up time (BUT)
timeFrame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
measure: Distance Uncorrected visual acuity (UCVA)
timeFrame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
measure: Fitness of the contact
timeFrame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days
Other outcomes:
measure: efficacy evaluation indexes
timeFrame: on the day of wearing the lens and after wearing lenses for 30 days and 90 days
Locations:
city: Taoyuan
country: China
facility: BenQ Materials Corporation
Study officials:
References: