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This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.
The study will be a prospective, randomized, single blind, bilateral dispensing study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Lens 1 | Experimental | Investigational soft contact lenses worn daily. |
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| Test Lens 2 | Experimental | Investigational soft contact lenses worn daily. |
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| Control lens | Active Comparator | Spectacle lenses worn daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Lens 1 | Device | Investigational soft contact lens with asperic optical design to control myopia progression. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spherical Equivalent Refraction | Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia. | Baseline and every 6 months post-baseline for 2 years |
| Axial Length (Axial Elongation) | Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up. | Baseline and every 6 months post-baseline for 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xu Cheng, MD, PhD | Principal Clinical Scientist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Tianjin Eye Hospital | Tianjin | 300020 | China |
Of those 150 screened subjects, 3 were not eligible to participate in the study and 10 were not randomized to the study lens groups. 115 subjects completed all study visits without a major protocol deviation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Lens 1 | Investigational soft contact lenses worn daily. |
| FG001 | Test Lens 2 | Investigational soft contact lenses worn daily. |
| FG002 | Control Lens | Control spectacle lenses worn daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline summary was conducted on all subjects who randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Lens 1 | Investigational soft contact lens worn daily. |
| BG001 | Test Lens 2 | Investigational soft contact lens worn daily. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Spherical Equivalent Refraction | Spherical equivalent refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor (WAM-5500) and descriptively summarized for each follow-up. Higher spherical refraction indicates progression in Myopia. | Analysis was conducted on all randomized subjects who have at least one data point. | Posted | Mean | Standard Deviation | diopter (D) | Baseline and every 6 months post-baseline for 2 years | eyes | eyes |
|
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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 | Test Lens 1 | Investigational soft contact lenses worn daily. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| XU CHENG, PRINCIPAL CLINICAL SCIENTIST | Vistakon USA | 1 904 443-1245 | xcheng6@its.jnj.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Test Lens 2 | Device | Investigational soft contact lens with asperic optical design to control myopia progression. |
|
| Control Lens | Device | Spectacle Lenses. |
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| Lost to Follow-up |
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| Difficulty of handling lens |
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| BG002 | Control Lens | Spectacle lenses worn daily. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG002 | Control Lens | Spectacle lenses worn daily. |
|
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| Primary | Axial Length (Axial Elongation) | Axial length was measured with the IOLMaster at baseline and every 6 months post-baseline for 2 years. Axial length was descriptively summarized for each follow-up. | Analysis was conducted on all randomized subjects who have at least one data point. | Posted | Mean | Standard Deviation | millimeter (mm) | Baseline and every 6 months post-baseline for 2 years | eyes | eyes |
|
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| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Test Lens 2 | Investigational soft contact lenses worn daily. | 0 | 44 | 0 | 44 |
| EG002 | Control Lens | Control spectacle lenses worn daily. | 0 | 47 | 0 | 47 |
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| Change from baseline 12 months |
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| Change from baseline 18 months |
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| Change from baseline 24 months |
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