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

NCT06616519 | Completed

• 1 other identifier: MSENC1 202101
• 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 MSENCI soft hydrophilic contact lenses with Oxypure color soft hydrophilic contact lenses used as the control product.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• efficacy evaluation indexes

  Binocular CVA with lenses after wearing lenses, 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 MSENCI lenses

EXPERIMENTAL

BenQ Materials Daily disposable contact lens wears for 1 month

Device: BenQ Materials MSENCI soft hydrophilic contact lenses

Visco Oxypure lens

ACTIVE COMPARATOR

Device: Visco Oxypure Color soft hydrophilic contact lenses

Interventions

BenQ Materials MSENCI soft hydrophilic contact lenses DEVICE

Test lenses were to be worn for approximately 90 days.

BenQ Materials MSENCI lenses

Visco Oxypure Color soft hydrophilic contact lenses DEVICE

Control lenses were to be worn for approximately 90 days

Visco Oxypure 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, no gender limitation;
• Soft hydrophilic contact lenses worn should be from 0.00D to -12.00D;
• Subjects should have normal binocular conditions without any abnormality or diseases except for ametropia;
• The optimal binocular CVA with glasses ≥ 1.0;
• The astigmatism should be ≤1.5D;
• Binoculus BUT \>5s;
• should accept follow-ups for at least 90 days and wear the contact lens as required in the protocol;
• should understand the purpose of the trial, volunteer to attend and sign the Informed Consent Form by the subjects themselves or their legal guardians.

You may not qualify if:

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

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 19, 2024
• First Posted: September 27, 2024
• Study Start: May 18, 2021
• Primary Completion: May 1, 2022
• Study Completion: August 25, 2022
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)