MyopiaNCT05273606

Short-term Clinical Performance of Multifocal Soft Contact Lens

A study testing MiSight mutifocal soft contact lens and Proclear 1 Day soft contact lens in people with Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 8 to 12 years
Conditions the study is for: Myopia
What is being tested?: MiSight mutifocal soft contact lens and Proclear 1 Day soft contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: 16 Jul 2022to 16 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

• Prior to being considered eligible to participate in this study, each subject MUST:
Be between 8 and 12 years of age inclusive at the baseline examination.
Have:
read the Informed Assent,
been given an explanation of the Informed Assent,
indicated an understanding of the Informed Assent and

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signed the Informed Assent Form.
Have their parent or legal guardian:
read the Informed Consent,
been given an explanation of the Informed Consent,
indicated an understanding of the Informed Consent and
signed the Informed Consent Form.
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.
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.
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.)
Meet the following refractive criteria determined by cycloplegic autorefraction at baseline:
Spherical refractive error： between -0.75 and -4.00 D inclusive,
Astigmatism: ≤-0.75 D,
Anisometropia: ≤1.50D,
Best-corrected visual acuity :≥0.8.

Who cannot join

• Subjects may not be considered eligible if ANY of the following apply:
Subject has regular use of ocular medications.
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.
A history of ocular trauma or ocular surgery in the last 8 weeks.
Subject has worn rigid gas permeable contact lenses in the last 6 weeks, including orthokeratology lenses.
Abnormal secretion or excretion of tear fluid, infection of the tear ducts, or other recurrent ocular infections.

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A known allergy to fluorescein, benoxinate, proparacaine, or tropicamide.
Keratoconus or an irregular cornea.
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.
Strabismus, amblyopia patients, only one eye meets the admission conditions.
Subjects have received any myopia control treatment.
Subject is currently an active participant in another clinical study.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060

Other trials in China

About this study

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

Read the 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
Being tested: MiSight mutifocal soft contact lens, Proclear 1 Day soft contact lens
Medical subject headings: Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MiSight mutifocal soft contact lensDevice
Subjects will wear MiSight™ multifocal soft contact lenses for 1 month.
Proclear 1 Day soft contact lensDevice
Proclear™ 1 Day soft contact lens will be worn for baseline evaluation.

Study groups in NCT05273606
Study group	Role	What they receive
Experimental Group	Experimental	one group for contact lens Receives: Device: MiSight mutifocal soft contact lens; Device: Proclear 1 Day soft contact lens

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the contrast sensitivity visual function (CSF) relative to baseline at 1 month
Measured: Proclear baseline;VMisight baseline; 1 week; 1month

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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
Measured: Proclear baseline;Misight baseline；1 week;1month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jul 202216 Dec 2022

First posted10 Mar 2022
Study start16 Jul 2022
Primary completion13 Dec 2022
Study completion16 Dec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for MyopiaStudies of the same condition, open and under way.
More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05273606
Sponsor's protocol ID: 2021KYPJ202
Status last verified: Dec 2022
First submitted: 28 Feb 2022
Last updated: 28 Dec 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Effect of IOP Lowering on Progressive HM
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Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study of Short-term Clinical Performance of Multifocal Soft Contact Lens
ClinicalTrials.gov ID: NCT05273606
Acronym / sponsor ID: 2021KYPJ202
Conditions: Myopia
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
Study start: 16 Jul 2022 (actual)
Primary completion: 13 Dec 2022 (actual)
Study completion: 16 Dec 2022 (estimated)
First posted: 10 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental Group	Experimental	Device: MiSight mutifocal soft contact lens, Device: Proclear 1 Day soft contact lensone group for contact lens

Who may qualify

Ages: 8 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (20 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MiSight mutifocal soft contact lensSubjects will wear MiSight™ multifocal soft contact lenses for 1 month.	Device	Experimental Group
Proclear 1 Day soft contact lensProclear™ 1 Day soft contact lens will be worn for baseline evaluation.	Device	Experimental Group

Primary outcome

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

3 secondary outcomes

Patients' subjective acceptability to multifocal soft contact lens
Time frame: Proclear baseline; Misight baseline; 1 week; 1month
Doctors' clinical evaluation to multifocal soft contact lens
Time frame: 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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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Recruiting
Mobility Performance in Daily Activities Among Children Wearing Spectacle Lenses
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiao Yang, PhD study chair

Zhongshan Ophthalmic Center, Sun Yat-sen University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MiSight mutifocal soft contact lens and Proclear 1 Day soft contact lens in people with Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the contrast sensitivity visual function (CSF) relative to baseline at 1 month (time frame: Proclear baseline;VMisight baseline; 1 week; 1month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05273606.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.