Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Visioncare Research Ltd. | OTHER |
Not provided
Not provided
Not provided
The purpose of this study is to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
Subjects were randomized to wear test or control soft contact lens to determine whether a new type of soft contact lens with a unique optical design (dual focus) is effective at slowing the progression of myopia (near-sightedness) in children.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Focus Soft Contact Lens | Experimental | Dual Focus Soft Contact Lens |
|
| Single Vision Soft Contact Lens | Placebo Comparator | Single Vision Soft Contact Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Focus Soft Contact Lens | Device |
| ||
| Single Vision Soft Contact Lens |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Refractive Error Relative to Baseline | Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline. | 12 months |
| Change in Refractive Error Relative to Baseline | Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline. | 24 months |
| Change in Refractive Error Relative to Baseline | Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline. | 36 months |
| Change in Axial Length Relative to Baseline | Mean change in axial length measurement, in millimeters at 12 months, relative to baseline. | 12 months |
| Change in Axial Length Relative to Baseline | Mean change in axial length measurement, in millimeters at 24 months, relative to baseline. | 24 months |
| Change in Axial Length Relative to Baseline | Mean change in axial length measurement, in millimeters at 36 months, relative to baseline. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). | Baseline |
| Number of Participants With Biomicroscopic Findings Greater Than Grade 2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| José Manuel González-Méijome | University of Minho | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Waterloo School of Optometry | Waterloo | Ontario | N2L 3G1 | Canada | ||
| University of Minho Clinical & Experiment Optometry Research Lab |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40132119 | Derived | Chamberlain P, Hammond DS, Bradley A, Arumugam B, Richdale K, McNally J, Hunt C, Young G. Eye growth and myopia progression following cessation of myopia control therapy with a dual-focus soft contact lens. Optom Vis Sci. 2025 May 1;102(5):353-358. doi: 10.1097/OPX.0000000000002244. Epub 2025 Mar 24. | |
| 35086120 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dual Focus Soft Contact Lens | Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens |
| FG001 | Single Vision Soft Contact Lens | Single Vision Soft Contact Lens Single Vision Soft Contact Lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
|
| ||||||||||||||||||
| 12 Months Follow-up |
| |||||||||||||||||||
| 24 Months Follow-up |
| |||||||||||||||||||
| 36 Months Follow-up |
|
Subjects were randomized to wear dual focus soft contact lens and single vision soft contact lens.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dual Focus Soft Contact Lens | Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens |
| BG001 | Single Vision Soft Contact Lens | Single Vision Soft Contact Lens Single Vision Soft Contact Lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Refractive Error Relative to Baseline | Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 12 months, relative to baseline. | Posted | Mean | Standard Deviation | Diopters | 12 months | Eyes | Eyes |
|
From dispense of soft contact lenses till 36 months follow-up visit.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dual Focus Soft Contact Lens | Dual Focus Soft Contact Lens Dual Focus Soft Contact Lens |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Chamberlain | CooperVision Inc. | 925 730-6754 | PChamberlain@coopervision.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 26, 2012 | Dec 19, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2018 | Jan 20, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). |
| 12 months |
| Number of Participants With Biomicroscopic Findings | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). | 24 months |
| Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). | 36 months |
| Incidence of Adverse Events | Cumulative incidence of adverse events. | 12 months |
| Incidence of Adverse Events | Cumulative incidence of adverse events. | 24 months |
| Incidence of Adverse Events | Cumulative incidence of adverse events. | 36 months |
| Braga |
| 4710-057 |
| Portugal |
| National University of Singapore Faculty of Medicine | Singapore | 117597 | Singapore |
| Aston University Ophthalmic Research Group | Birmingham | B4 7ET | United Kingdom |
| Chamberlain P, Bradley A, Arumugam B, Hammond D, McNally J, Logan NS, Jones D, Ngo C, Peixoto-de-Matos SC, Hunt C, Young G. Long-term Effect of Dual-focus Contact Lenses on Myopia Progression in Children: A 6-year Multicenter Clinical Trial. Optom Vis Sci. 2022 Mar 1;99(3):204-212. doi: 10.1097/OPX.0000000000001873. |
| 31343513 | Derived | Chamberlain P, Peixoto-de-Matos SC, Logan NS, Ngo C, Jones D, Young G. A 3-year Randomized Clinical Trial of MiSight Lenses for Myopia Control. Optom Vis Sci. 2019 Aug;96(8):556-567. doi: 10.1097/OPX.0000000000001410. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Eyes |
|
|
| Primary | Change in Refractive Error Relative to Baseline | Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 24 months, relative to baseline. | Posted | Mean | Standard Deviation | Diopters | 24 months | Eyes | Eyes |
|
|
|
| Primary | Change in Refractive Error Relative to Baseline | Mean change in refractive error, measured with cycloplegic auto-refraction in Diopters at 36 months, relative to baseline. | Posted | Mean | Standard Deviation | Diopters | 36 months | Eyes | Eyes |
|
|
|
| Primary | Change in Axial Length Relative to Baseline | Mean change in axial length measurement, in millimeters at 12 months, relative to baseline. | Posted | Mean | Standard Deviation | mm | 12 months | Eyes | Eyes |
|
|
|
| Primary | Change in Axial Length Relative to Baseline | Mean change in axial length measurement, in millimeters at 24 months, relative to baseline. | Posted | Mean | Standard Deviation | mm | 24 months | Eyes | Eyes |
|
|
|
| Primary | Change in Axial Length Relative to Baseline | Mean change in axial length measurement, in millimeters at 36 months, relative to baseline. | Posted | Mean | Standard Deviation | mm | 36 months | Eyes | Eyes |
|
|
|
| Secondary | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). | Posted | Number | participants | Baseline |
|
|
|
| Secondary | Number of Participants With Biomicroscopic Findings Greater Than Grade 2 | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Number of Participants With Biomicroscopic Findings | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Number of Participants With Biomicroscopic Findings Greater Than Grade 2. | Cumulative incidence of biomicroscopic findings. Slit lamp severity greater than Grade 2 (based on a 0-4 scale, where 0=none and 4=severe). | Posted | Number | participants | 36 months |
|
|
|
| Secondary | Incidence of Adverse Events | Cumulative incidence of adverse events. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Incidence of Adverse Events | Cumulative incidence of adverse events. | Posted | Number | participants | 24 months |
|
|
|
| Secondary | Incidence of Adverse Events | Cumulative incidence of adverse events. | Posted | Number | participants | 36 months |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Single Vision Soft Contact Lens | Single Vision Soft Contact Lens Single Vision Soft Contact Lens | 0 | 74 | 0 | 74 | 0 | 74 |
Not provided
Not provided
| Bulbar Hyperemia |
|
| Limbal Hyperemia |
|
| Palpebral Hyperemia |
|
| Palpebral Roughness |
|
| Vascularization |
|
| "Other" Findings |
|
| Bulbar Hyperemia |
|
| Limbal Hyperemia |
|
| Palpebral Hyperemia |
|
| Palpebral Roughness |
|
| Vascularization |
|
| "Other" Findings |
|
| Bulbar Hyperemia |
|
| Limbal Hyperemia |
|
| Palpebral Hyperemia |
|
| Palpebral Roughness |
|
| Vascularization |
|
| "Other" Findings |
|
| Bulbar Hyperemia |
|
| Limbal Hyperemia |
|
| Palpebral Hyperemia |
|
| Palpebral Roughness |
|
| Vascularization |
|
| "Other" Findings |
|
| Localized allergic reaction - device related |
|
| Localized allergic reaction-not device related |
|
| Non-significant-Other-Device related |
|
| Non-significant-Other- Not device related |
|
| Foreign Body -Device related |
|
| Corneal event -Device related |
|
| Corneal event- Not device related |
|
| Meibomianitis - Not device related |
|
| Significant adverse events |
|
| Non-significant Other - Not device related |
|
| Non-significant infiltrative event Device related |
|
| Significant Adverse Events |
|
| Non-significant Other - Not device related |
|
| Non-significant infiltrative event-no device relat |
|
| Corneal event- device related |
|
| Significant Adverse Events |
|