Short-term Clinical Performance of Multifocal Soft Contact Lens

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: Recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: MiSight mutifocal soft contact lens; Device: Proclear 1 Day soft contact lens

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: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Xiao, PhD; Phone Number: 86-020-87330348; Email: yangx_zoc@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhongshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Xiao Yang, PhD; Phone Number: 86-020-87330348; Email: yangx_zoc@163.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Change in the contrast sensitivity visual function (CSF) relative to baseline at 1 month	Proclear baseline;VMisight baseline; 1 week; 1month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients' subjective acceptability to multifocal soft contact lens	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	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	Patients will wear contact lens when they are tested	Proclear baseline;Misight baseline；1 week;1month

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Investigators: Study Chair: Xiao Yang, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Anticipated): October 27, 2022
• Study Completion (Anticipated): December 16, 2022

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID 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