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| Name | Class |
|---|---|
| Visioncare Research Ltd. | OTHER |
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The purpose of this study is to investigate the effect of ceasing treatment with dual focus soft contact lenses.
This is a bilateral, open label, dispensing study with subjects who have completed dual focus soft contact lens wear treatment for either 3 or 6 years and who are refit to Proclear 1-day lens for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Focus for 3 years | Other | Group of subjects who completed dual focus soft contact lens wear treatment for 3 years |
|
| Dual Focus for 6 years | Other | Group of subjects who completed dual focus soft contact lens wear treatment for 6 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Vision Soft Contact Lens | Device | Subjects refit to Single Vision Soft Contact Lens for 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spherical Equivalent Refractive Error (SERE) | Change in spherical equivalent refractive error (SERE) relative to baseline (i.e., at end of dual focus soft contact lens wear treatment of either 3 or 6 years). Cycloplegic autorefraction was used to measure refractive error. | 1 year |
| Change in Axial Length (AL) | Change in axial length (AL) relative to baseline (i.e., at end of dual focus soft contact lens wear treatment of either 3 or 6 years). Partial coherence interferometry was used to measure axial length. | 1 year |
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Inclusion Criteria:
Successfully completed the MIST-401 Parts 1 and 2
Visual acuity (VA) with CLs better than +0.25 log MAR (>6/12 or >20/40) in both eyes
No ocular pathology or other contraindication to contact lens wear
Where applicable (dependent on local requirements), have:
Where applicable (dependent on local requirements), have their parent or legal guardian:
Along with their parent or guardian (if applicable), 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 (if applicable), 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 a minimum of 10 hours per day, at least 6 days per week, for the duration of the study and to inform the study investigator if this schedule is interrupted. (Wearing time may be modified by the study staff for health reasons.)
Be in good general health, based on his/her and parent's/guardian's (if applicable) knowledge.
Have best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.
Exclusion Criteria:
Regular use of ocular medications (prescription or over-the-counter).
Current use of systemic medications which, in the investigators opinion, may significantly affect contact lens wear, tear film production, pupil size, accommodation or refractive state.
Pregnant or lactating or planning a pregnancy at the time of enrolment.
Known ocular or systemic disease such as, but not limited to: anterior uveitis or iritis, episcleritis or scleritis, glaucoma, Sjogren's syndrome, lupus erythematosus, scleroderma, or diabetes.
Any ocular, systemic or neuro-developmental conditions that in the investigators opinion, could influence refractive development.
Keratoconus or an irregular cornea.
Biomicroscope findings that would contraindicate contact lens wear including, but not limited to:
The investigator for any reason considers that it is not in the best interest of the subject to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Graeme Young | Visioncare Research Ltd. | Study Director |
| 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 |
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Eighty-three participants were enrolled, and 76 participants completed the study. The primary reason was due to decreased vision related to astigmatism.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dual Focus for 3 Years | Group of subjects who completed dual focus soft contact lens wear treatment for 3 years. Subjects refit to Single Vision Soft Contact Lens for 1 year. |
| FG001 | Dual Focus for 6 Years | Group of subjects who completed dual focus soft contact lens wear treatment for 6 years. Subjects refit to Single Vision Soft Contact Lens for 1 year. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Eighty-three participants were enrolled, and demographic data include all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Dual Focus for 3 Years | Group of subjects who completed dual focus soft contact lens wear treatment for 3 years |
| BG001 | Dual Focus for 6 Years | Group of subjects who completed dual focus soft contact lens wear treatment for 6 years |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Spherical Equivalent Refractive Error (SERE) | Change in spherical equivalent refractive error (SERE) relative to baseline (i.e., at end of dual focus soft contact lens wear treatment of either 3 or 6 years). Cycloplegic autorefraction was used to measure refractive error. | [Not specified] | Posted | Mean | Standard Deviation | D | 1 year | Eyes | Eyes |
|
The data was collected in time frame of 1 year of study.
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| 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 for 3 Years | Group of subjects who completed dual focus soft contact lens wear treatment for 3 years |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjuctivitis | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Chamberlain | Coopervision | 9257306754 | pchamberlain@coopervision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2018 | Sep 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Braga |
| 4710-057 |
| Portugal |
| National University of Singapore Faculty of Medicine | Singapore | 117597 | Singapore |
| Aston University Ophthalmic Research Group | Birmingham | B4 7ET | United Kingdom |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Proportion may not sum to 100% as participants selecting more than one race will be counted multiple times. | Count of Participants | Participants |
|
|
|
| Primary | Change in Axial Length (AL) | Change in axial length (AL) relative to baseline (i.e., at end of dual focus soft contact lens wear treatment of either 3 or 6 years). Partial coherence interferometry was used to measure axial length. | [Not Specified] | Posted | Mean | Standard Deviation | mm | 1 year | Eyes | Eyes |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 2 |
| 40 |
| EG001 | Dual Focus for 6 Years | Group of subjects who completed dual focus soft contact lens wear treatment for 6 years | 0 | 43 | 0 | 43 | 3 | 43 |
| Corneal Staining | Product Issues | Systematic Assessment |
|
| Discomfort | Product Issues | Systematic Assessment |
|
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