MyopiaNCT04238897

To Evaluate the Efficacy and Safety of Aspherical Soft Contact Lens in Myopia Control

A study testing soft contact lens in people with Myopia, run by APP Vision Care Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this study is to demonstrate that the Ticon Aspherical Daily Disposable Soft Contact Lens could retard myopia progress in youth Read more about this study

Who is it for?: Ages 9 to 15 years
Conditions the study is for: Myopia
What is being tested?: soft contact lens
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: No sites listed yet
Study dates: 4 May 2016to 6 Jun 2019
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 9 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

Myopia (SE) between -1.00D to -8.00D
Astigmatism less than or equal to 1.75D
Myopia progression ≧0.75 D in the past 12 months
Best Corrected Visual Acuity (BCVA): 0.9 Snellen or better
Willingness to wear contact lens constantly
Availability for follow-up for at least 1 year
Parent's understanding and acceptance
have an acceptable surrogate capable of giving legally authorized consent on behalf of the subject

Who cannot join

Anisometropia greater than 2.00D
Presence of ocular disease preventing wear of contact lens
Severe ocular or systemic allergies
Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
Ocular or systemic condition that might affect refractive development
Atropine/Pirenzepine treatment for myopia control in the past 1 month
Prior use of Ortho-K lenses
Dry eye with Schimer Test (basal secretion test) < 5mm/5min or other physical condition that would contraindicate contact lens wear

About this study

Official title: A Prospective Randomized Control Study to Evaluate the Effect of Ticon Aspherical Daily Disposable Soft Contact Lens on Myopia Control

The objective of this study is to demonstrate that the Ticon Aspherical Daily Disposable Soft Contact Lens could retard myopia progress in youth

Read the detailed description

This study is designed as a prospective, multicenter, randomized, double blinded, controlled, paired-eye comparison study. At least 60 evaluable subjects with myopia progression ≧ 0.75 D in the past 12 months will be recruited from 2 study sites. The experimental soft contact lens with aspherical design (Ticon Aspherical) will be randomly assigned to either the right eye or the left eye of the subject , then the fellow eye will be assigned a control lens with a single vision distance (SVD) soft contact lens (Ticon). Both lenses will be worn at least 8 hours a day, 5 days a week for 1 year. All lenses will be replaced every day. Brief assessment of the clinical findings will be followed up for one year at 1 day, 1 week, 1, 3, 6, 9, 12 months upon allocation. The primary efficacy outcome is change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months. The secondary outcome is change in axial eye length (AXL) measured over 12 months. The secondary outcome measure is used to corroborate any changes in SER

Conditions: Myopia
Being tested: soft contact lens
Keywords: myopia control, soft contact lens, eye diseases
Medical subject headings: Myopia, Eye Diseases

What participants receive

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

soft contact lensDevice

Study groups in NCT04238897
Study group	Role	What they receive
Ticon Aspherical Daily Disposable Soft Contact Lens	Experimental	The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months. Receives: Device: soft contact lens
Ticon Daily Soft Contact Lens	Placebo comparator	The subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months. Receives: Device: soft contact lens

What is being measured

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

Spherical Equivalent Refraction (SER)
The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.
Measured: 12 months

Secondary outcomes (1)

Axial Eye Length (AXL)
The change in axial eye length (AXL) measured over 12 months. Axial length is measured after cycloplegia using optical biometry.
Measured: 12 months

Timeline

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

4 May 20166 Jun 2019

First posted23 Jan 2020
Study start4 May 2016
Primary completion12 Sep 2018
Study completion6 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MyopiaStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Model description: paired-eye design
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04238897
Sponsor's protocol ID: 1011128M
Status last verified: Jan 2020
First submitted: 19 Jan 2020
Last updated: 23 Jan 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Shen EP, Chu HS, Cheng HC, Tsai TH. Center-for-Near Extended-Depth-of-Focus Soft Contact Lens for Myopia Control in Children: 1-Year Results of a Randomized Controlled Trial. Ophthalmol Ther. 2022 Aug;11(4):1577-1588. doi: 10.1007/s40123-022-00536-5. Epub 2022 Jun 23.
PubMed 35737291

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?

Official record

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
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Randomized Control Study to Evaluate the Effect of Ticon Aspherical Daily Disposable Soft Contact Lens on Myopia Control
ClinicalTrials.gov ID: NCT04238897
Acronym / sponsor ID: 1011128M
Conditions: Myopia
Keywords: myopia control, soft contact lens, eye diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: APP Vision Care Inc.Industry (pharma, biotech, devices)
Collaborators: National Taiwan University Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Study start: 4 May 2016 (actual)
Primary completion: 12 Sep 2018 (actual)
Study completion: 6 Jun 2019 (actual)
First posted: 23 Jan 2020 (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.

The objective of this study is to demonstrate that the Ticon Aspherical Daily Disposable Soft Contact Lens could retard myopia progress in youth

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: paired-eye design

Arm	Type	Receives
Ticon Aspherical Daily Disposable Soft Contact Lens	Experimental	Device: soft contact lensThe subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months.
Ticon Daily Soft Contact Lens	Placebo comparator	Device: soft contact lensThe subject will be requested to wear lens 8 hours a day, 5 days a week at least. The contact lens will be worn and replaced every day. All subjects will be followed for 1 year post device allocation with a brief clinical assessment at 1 day, 1 week, 1, 3, 6, 9, 12 months.

Who may qualify

Ages: 9 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Myopia (SE) between -1.00D to -8.00D
Astigmatism less than or equal to 1.75D
Myopia progression ≧0.75 D in the past 12 months
Best Corrected Visual Acuity (BCVA): 0.9 Snellen or better
Willingness to wear contact lens constantly

Key exclusion criteria (8 listed)

Anisometropia greater than 2.00D
Presence of ocular disease preventing wear of contact lens
Severe ocular or systemic allergies
Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
Ocular or systemic condition that might affect refractive development

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
soft contact lens	Device	Ticon Aspherical Daily Disposable Soft Contact Lens, Ticon Daily Soft Contact Lens

Primary outcome

Spherical Equivalent Refraction (SER)
Time frame: 12 months
The change in spherical equivalent refraction (SER) measured by cycloplegic autorefraction over 12 months.

1 secondary outcome

Axial Eye Length (AXL)
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
Derived from this study: PubMed 35737291Shen EP, Chu HS, Cheng HC, Tsai TH. Center-for-Near Extended-Depth-of-Focus Soft Contact Lens for Myopia Control in Children: 1-Year Results of a Randomized Controlled Trial. Ophthalmol Ther. 2022 Aug;11(4):1577-1588. doi: 10.1007/s40123-022-00536-5. Epub 2022 Jun 23.

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
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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.

Tzu-Hsun Tsai, M.D. study chair

National Taiwan University Hospital

Elizabeth P Shen, M.D. principal investigator

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hsiao-Sang Chu, M.D. principal investigator

National Taiwan University Hospital

Questions about this trial

What is this clinical trial studying?

A study testing soft contact lens in people with Myopia, run by APP Vision Care Inc..

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 8 inclusion and 8 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: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Spherical Equivalent Refraction (SER) (time frame: 12 months). 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 NCT04238897, which also lists 1 linked publication.

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 23 Jan 2020.