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This study is to investigate whether novel soft contact lens optical designs can slow myopia progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Soft Contact Lens B | Experimental | Lenses will be worn in a daily disposable modality |
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| Test Soft Contact Lens C | Experimental | Lenses will be worn in a daily disposable modality |
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| Spectacle Lenses | Active Comparator | Control spectacle lenses worn daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Soft Contact Lens B | Device | Test lenses to be worn in daily wear modality |
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| Measure | Description | Time Frame |
|---|---|---|
| Axial Length (Axial Elongation) | Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision. | Baseline and every 6 months post-baseline up to 3 years |
| Spherical Equivalent Refraction | Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate progression in Myopia. | Baseline and every 6 months post-baseline up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Hung Hom | Kowloon | Hong Kong |
Of those 221 screened subjects, 56 were ineligible to participate in the study and 13 were eligible but not randomized to the study lens groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Soft Contact Lens B | Lenses will be worn in a daily disposable modality |
| FG001 | Test Soft Contact Lens C | Lenses will be worn in a daily disposable modality |
| FG002 | Spectacle Lenses | Control spectacle lenses worn daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline summary was conducted on all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Test Soft Contact Lens B | Lenses will be worn in a daily disposable modality |
| BG001 | Test Soft Contact Lens C | Lenses will be worn in a daily disposable modality |
| 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 | Axial Length (Axial Elongation) | Axial Length was measured with the IOLMaster at baseline, and then every 6 months throughout the course of the study. Five measurements were collected for each eye at each visit and the average of the 5 measurements were used for the analysis. Higher values of axial elongation indicate worse vision. | 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 up to 3 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 | Spectacle Lenses | Control spectacle lenses worn daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Slit-lamp finding | Eye disorders | Non-systematic Assessment | Slit Lamp findings Grade 2 or less requiring treatment. |
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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 Soft Contact Lens C | Device | Test lenses to be worn in a daily wear modality |
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| Active Comparator | Device | Control spectacle lenses to be worn in a daily wear modality |
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| Dryness |
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| Relocation |
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| Lens discomfort |
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| Lens handling difficulty |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Stroke |
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| Unsatisfactory lens fitting performance |
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| Unsatisfactory physiological response |
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| Unsatisfactory visual response |
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| Near vision blur |
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| BG002 | Spectacle Lenses | Control 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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Lenses will be worn in a daily disposable modality.
| OG002 | Test Soft Contact Lens C | Lenses will be worn in a daily disposable modality. |
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| Primary | Spherical Equivalent Refraction | Spherical Equivalent Refraction was computed from the sphero-cylindrical refraction measured with an open-field auto refractor. The median of 3 repeated measurements, each of which was the average of 3 consecutive readings, was used for the analysis. Higher values of spherical refraction indicate 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 up to 3 years | eyes | eyes |
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| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Test Soft Contact Lens B | Lenses will be worn in a daily disposable modality. | 0 | 51 | 7 | 51 |
| EG002 | Test Soft Contact Lens C | Lenses will be worn in a daily disposable modality. | 0 | 50 | 4 | 50 |
| EG003 | Not Randomized | Subjects who met the all study eligible criteria but did not randomize to the study arm. | 0 | 13 | 0 | 13 |
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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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| Change from baseline 30 months |
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| Change from baseline 36 months |
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