Short-term Clinical Performance of Multifocal Soft Contact Lens

NCT ID: NCT05273606

Last Updated: 2022-12-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-16
• Study Completion Date: 2022-12-16

Brief Summary

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.

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.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

one group for contact lens

Group Type: EXPERIMENTAL

MiSight mutifocal soft contact lens

Intervention Type: DEVICE

Subjects will wear MiSight™ multifocal soft contact lenses for 1 month.

Proclear 1 Day soft contact lens

Intervention Type: DEVICE

Proclear™ 1 Day soft contact lens will be worn for baseline evaluation.

Interventions

MiSight mutifocal soft contact lens

Subjects will wear MiSight™ multifocal soft contact lenses for 1 month.

Intervention Type: DEVICE

Proclear 1 Day soft contact lens

Proclear™ 1 Day soft contact lens will be worn for baseline evaluation.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xiao Yang

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiao Yang, PhD

Role: STUDY_CHAIR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2021KYPJ202

Identifier Type: -

Identifier Source: org_study_id