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OpenTrials
Completed

NCT Number: NCT06616519

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BenQ Materials Corporation

Taoyuan, 33341, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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Exclusion criteria

  • 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.

Treatment and study plan

BenQ Materials MSENCI soft hydrophilic contact lenses

Device

Test lenses were to be worn for approximately 90 days.

Visco Oxypure Color soft hydrophilic contact lenses

Device

Control lenses were to be worn for approximately 90 days

Primary outcomes

  1. efficacy evaluation indexes

    Time frame: after wearing lenses for 7 days

    Binocular CVA with lenses after wearing lenses, The percentage of changes in iris color

Secondary outcomes

  1. Time of Break up time (BUT)

    Time frame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days

    Comparison of BUT time results between the experimental group and control group

  2. Distance Uncorrected visual acuity (UCVA)

    Time frame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days

    Comparison of distance uncorrected visual acuity results between the experimental group and control group

  3. Fitness of the contact

    Time frame: on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days

    the position of lens on the ocular surface, the coverage, tightness and movability of lens

Other outcomes

  1. efficacy evaluation indexes

    Time frame: on the day of wearing the lens and after wearing lenses for 30 days and 90 days

    Instant iris color change after wearing lenses Binocular CVA with lenses ≥ 1.0

Sponsors and collaborators

Lead sponsor

BenQ Materials Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 27, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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