Short-term Clinical Performance of Multifocal Soft Contact Lens

October 27, 2022 updated by: Xiao Yang, Zhongshan Ophthalmic Center, Sun Yat-sen University

A Clinical Study of Short-term Clinical Performance of Multifocal Soft Contact Lens

The study is aimed to observe the short-term clinical performance of MiSight™ multifocal soft contact lens compared with Proclear™ 1day, including objective examination, subjective acceptability of wearers, and doctors' evaluation of the clinical manifestations of lenses.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Compared with Proclear™ 1day, observe the short-term clinical performance of MiSight™ multifocal soft contact lens including objective examination, subjective acceptability of wearers, and doctors' evaluation of the clinical manifestations of lenses in 1 month.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center, Sun Yat-sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Prior to being considered eligible to participate in this study, each subject MUST:

    1. Be between 8 and 12 years of age inclusive at the baseline examination.

    2. Have:

      1. read the Informed Assent,
      2. been given an explanation of the Informed Assent,
      3. indicated an understanding of the Informed Assent and
      4. signed the Informed Assent Form.

    3. Have their parent or legal guardian:

      1. read the Informed Consent,
      2. been given an explanation of the Informed Consent,
      3. indicated an understanding of the Informed Consent and
      4. signed the Informed Consent Form.
    4. Along with their parent or guardian, be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.
    5. Along with their parent or guardian, agree to maintain the visit schedule and be able to keep all appointments as specified in the study protocol for the duration of the study.
    6. Agree to wear the assigned contact lenses for the duration of the 1-month study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)

    7. Meet the following refractive criteria determined by cycloplegic autorefraction at baseline:

      1. Spherical refractive error： between -0.75 and -4.00 D inclusive,
      2. Astigmatism: ≤-0.75 D,
      3. Anisometropia: ≤1.50D,
    8. Best-corrected visual acuity :≥0.8.

Exclusion Criteria:

  • • Subjects may not be considered eligible if ANY of the following apply:

    1. Subject has regular use of ocular medications.
    2. Any systemic disease which is not suggested to wear contact lens or current use of systemic medications which may significantly affect contact lens wear, visual function, or refractive state.
    3. A history of ocular trauma or ocular surgery in the last 8 weeks.
    4. Subject has worn rigid gas permeable contact lenses in the last 6 weeks, including orthokeratology lenses.
    5. Abnormal secretion or excretion of tear fluid, infection of the tear ducts, or other recurrent ocular infections.
    6. A known allergy to fluorescein, benoxinate, proparacaine, or tropicamide.
    7. Keratoconus or an irregular cornea.
    8. Subjects who have been in a special environment such as dryness, serious dust, or volatile chemicals for a long time affect the wear of contact lenses.
    9. Strabismus, amblyopia patients, only one eye meets the admission conditions.
    10. Subjects have received any myopia control treatment.
    11. Subject is currently an active participant in another clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
one group for contact lens
Device: MiSight mutifocal soft contact lens
Subjects will wear MiSight™ multifocal soft contact lenses for 1 month.
Device: Proclear 1 Day soft contact lens
Proclear™ 1 Day soft contact lens will be worn for baseline evaluation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in the contrast sensitivity visual function (CSF) relative to baseline at 1 month
Time Frame: Proclear baseline;VMisight baseline; 1 week; 1month
Proclear baseline;VMisight baseline; 1 week; 1month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients' subjective acceptability to multifocal soft contact lens
Time Frame: Proclear baseline; Misight baseline; 1 week; 1month
The patients will be asked to complete questionnaires at each visit regarding vision, lens comfort, the difficulty of lens insert and removal, etc. of the multifocal contact lens.
Proclear baseline; Misight baseline; 1 week; 1month
Doctors' clinical evaluation to multifocal soft contact lens
Time Frame: Proclear baseline; Misight baseline; 1 week; 1month
The doctors will be asked to complete questionnaires regarding the difficulty of fitting procedure and general impression of the multifocal contact lens.
Proclear baseline; Misight baseline; 1 week; 1month
Change in the contact lens corrected visual acuity relative to baseline
Time Frame: Proclear baseline;Misight baseline；1 week;1month
Patients will wear contact lens when they are tested
Proclear baseline;Misight baseline；1 week;1month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Xiao Yang, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021KYPJ202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings