MyopiaNCT06528860
Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults
A study testing MiSight® 1 day soft contact lenses and Proclear® 1 day soft contact lenses in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Myopia
- What is being tested?
- MiSight® 1 day soft contact lenses and Proclear® 1 day soft contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-25 years;
- Myopia progression <= -0.50D in either eye in the past year (evaluated by -manifest refraction);
- The subject eye: cycloplegic spherical equivalent ranges from -2.00D to -6.0D and cylinder power doesn't exceed -1.50D;
- The subject eye's best corrected visual acuity <= logMAR 0.1;
- Anisometropia does not exceed 1.50D.
Who cannot join
- Current use of MC interventions or prior use of MC interventions within the past 6 months;
- Disease or anatomical factors that affect the wearing of contact lenses;
- History of myopia correction surgery;
- Suffering from ocular or systemic diseases that may be related to myopia, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.;
- pregnant female;
- Other conditions deemed unsuitable by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200041
Xiangui He, (86)15000755422, xianhezi@163.com
Hotin Wu, (86)19821287621, 24499980@sjtu.edu.cn
About this study
Official title: The Effectiveness and Acceptability of Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults: A Randomized Controlled Trial
This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.
Read the detailed description
It has long been believed that the progression of myopia mainly occurs during the elementary to high school stages. However, some studies and clinical practice suggest that a considerable proportion of adults still experience myopia progression in their adulthood, especially in those who have prolonged near work or screen usage time. At present, there is insufficient evidence on whether these population needs myopia control intervention. Most adults experiencing myopia progression do not receive appropriate myopic intervention measures, leading to an increase of dioptre, which may affect the quality of daily life, and raise the risk of high myopia and blinding myopia complications.
This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.
- Conditions
- Myopia
- Being tested
- MiSight® 1 day soft contact lenses, Proclear® 1 day soft contact lenses
- Keywords
- Myopia, Dual-focus contact lenses, Young adults, Adult myopia progression
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiSight® 1 day soft contact lensesDevice
Also called CooperVision
Dual-focus contact lenses, daily disposable, material: omafilcon A, water content: 60%.
Proclear® 1 day soft contact lensesDevice
Also called CooperVision
Single-vision contact lenses, daily disposable, material: omafilcon A, water content: 60%.
| Study group | Role | What they receive |
|---|---|---|
| Dual-focus CL | Experimental | Wearing dual-focus CL for 2 years Receives: Device: MiSight® 1 day soft contact lenses |
| Single-vision CL | Placebo comparator | Wearing single-vision CL for 2 years Receives: Device: Proclear® 1 day soft contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cycloplegic spherical equivalent after 2 years
The difference in the change of cycloplegic spherical equivalent between the intervention group and the control group.
Measured: 2 years after the baseline
Secondary outcomes (1)
Change in axial length after 2 years
The difference in the change of axial length between the intervention group and the control group.
Measured: 2 years after the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start31 Aug 2024 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Intervention Group: Daily disposable bifocal soft corneal contact lenses: MiSight® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%). Control Group: Daily disposable single-focus soft corneal contact lenses: Proclear® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiangui He, Principal investigator, Shanghai Eye Disease Prevention & Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528860
- Sponsor's protocol ID
- QX-2024-A-002
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruiz-Pomeda A, Villa-Collar C. Slowing the Progression of Myopia in Children with the MiSight Contact Lens: A Narrative Review of the Evidence. Ophthalmol Ther. 2020 Dec;9(4):783-795. doi: 10.1007/s40123-020-00298-y. Epub 2020 Sep 11.
PubMed 32915454Bullimore MA, Lee SS, Schmid KL, Rozema JJ, Leveziel N, Mallen EAH, Jacobsen N, Iribarren R, Verkicharla PK, Polling JR, Chamberlain P. IMI-Onset and Progression of Myopia in Young Adults. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):2. doi: 10.1167/iovs.64.6.2.
PubMed 37126362
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Acceptability of Dual-focus Soft Contact Lenses for Controlling Rapid Progressive Myopia in Young Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06528860
- Acronym / sponsor ID
- QX-2024-A-002
- Conditions
- Myopia
- Keywords
- Myopia, Dual-focus contact lenses, Young adults, Adult myopia progression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 31 Aug 2024 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 30 Jul 2024 (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.
This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.
Detailed description
It has long been believed that the progression of myopia mainly occurs during the elementary to high school stages. However, some studies and clinical practice suggest that a considerable proportion of adults still experience myopia progression in their adulthood, especially in those who have prolonged near work or screen usage time. At present, there is insufficient evidence on whether these population needs myopia control intervention. Most adults experiencing myopia progression do not receive appropriate myopic intervention measures, leading to an increase of dioptre, which may affect the quality of daily life, and raise the risk of high myopia and blinding myopia complications.
This study aims to evaluate the effectiveness and acceptability of dual-focus soft contact lenses in controlling rapid myopia progression in adults through a randomized controlled trial. By applying myopia control measures to the adult population, we hope to provide scientific evidence for the effective control of adult myopia progression and offer insights into the understanding of myopia progression during early adulthood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Intervention Group: Daily disposable bifocal soft corneal contact lenses: MiSight® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%). Control Group: Daily disposable single-focus soft corneal contact lenses: Proclear® 1 day soft contact lens (CooperVision, material: omafilcon A, water content: 60%)
| Arm | Type | Receives |
|---|---|---|
| Dual-focus CL | Experimental | Device: MiSight® 1 day soft contact lensesWearing dual-focus CL for 2 years |
| Single-vision CL | Placebo comparator | Device: Proclear® 1 day soft contact lensesWearing single-vision CL for 2 years |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-25 years;
- Myopia progression <= -0.50D in either eye in the past year (evaluated by -manifest refraction);
- The subject eye: cycloplegic spherical equivalent ranges from -2.00D to -6.0D and cylinder power doesn't exceed -1.50D;
- The subject eye's best corrected visual acuity <= logMAR 0.1;
- Anisometropia does not exceed 1.50D.
Key exclusion criteria (6 listed)
- Current use of MC interventions or prior use of MC interventions within the past 6 months;
- Disease or anatomical factors that affect the wearing of contact lenses;
- History of myopia correction surgery;
- Suffering from ocular or systemic diseases that may be related to myopia, such as Marfan syndrome, retinopathy of prematurity, diabetes, etc.;
- pregnant female;
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® 1 day soft contact lensesAlso: CooperVisionDual-focus contact lenses, daily disposable, material: omafilcon A, water content: 60%. | Device | Dual-focus CL |
| Proclear® 1 day soft contact lensesAlso: CooperVisionSingle-vision contact lenses, daily disposable, material: omafilcon A, water content: 60%. | Device | Single-vision CL |
Primary outcome
Change in cycloplegic spherical equivalent after 2 years
Time frame: 2 years after the baseline
The difference in the change of cycloplegic spherical equivalent between the intervention group and the control group.
1 secondary outcome
Change in axial length after 2 years
Time frame: 2 years after the baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 32915454Ruiz-Pomeda A, Villa-Collar C. Slowing the Progression of Myopia in Children with the MiSight Contact Lens: A Narrative Review of the Evidence. Ophthalmol Ther. 2020 Dec;9(4):783-795. doi: 10.1007/s40123-020-00298-y. Epub 2020 Sep 11.
- Background: PubMed 37126362Bullimore MA, Lee SS, Schmid KL, Rozema JJ, Leveziel N, Mallen EAH, Jacobsen N, Iribarren R, Verkicharla PK, Polling JR, Chamberlain P. IMI-Onset and Progression of Myopia in Young Adults. Invest Ophthalmol Vis Sci. 2023 May 1;64(6):2. doi: 10.1167/iovs.64.6.2.
- Individual participant dataSharing planned: No
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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.
Xiangui He principal investigator
Shanghai Eye Disease Prevention & Treatment Center
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® 1 day soft contact lenses and Proclear® 1 day soft contact lenses in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 30 Jul 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangui He ((86)15000755422, xianhezi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cycloplegic spherical equivalent after 2 years (time frame: 2 years after the baseline). 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 NCT06528860, which also lists 2 linked publications.
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 30 Jul 2024.