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This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test/Control | Experimental | For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again. |
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| Control/Test | Experimental | For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A with new UV blocker | Device | Test Lens |
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| Measure | Description | Time Frame |
|---|---|---|
| Two-Point Light Spread Function | The two-point light spread function was assessed at visit 2 for each subject eye under two conditions with a distance filter and without a distance filter. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Two-point light spread function is defined that the as the minimum distance (mm) that two points of light are completely distinct. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and light source combination was reported across age groups. | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2 |
| Halos | The appearance of Halos was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Halos were quantified as the diameter (mm) of the outer edges of the Halo. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups. | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2 |
| Starburts | The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups. | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Glare Disability Threshold | The Glare disability threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported across age groups. |
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Inclusion Criteria:
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia Center for Sight | Statesboro | Georgia | 30642 | United States |
Subjects were stratified into two age groups: 18-39 and 40-65 using a 2:1 allocation. Subjects were randomized at each visit using a contralateral design.
A total of 62 subjects were into this study. Of those enrolled, 60 were assigned and administered a study lens. Two subjects were enrolled but not administered a study lens. All 60 subjects completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | OD:Test, OS:Control/ OD:Test, OS:Control | Subjects that were randomized to receive the Test lens in their right eye and the Control lens in their left eye at both visit 1 and visit 2. |
| FG001 | OD:Test, OS:Control/ OD:Control, OS:Test | Subjects that were randomized to receive at visit 1 the Test lens in their right eye and the Control lens in their left eye and at visit 2 was randomized to receive the Control lens in their right eye and the Test lens in their left eye. |
| FG002 | OD:Control, OS:Test/ OD:Test, OS:Control | Subjects that were randomized to receive at visit 1 the Control lens in their right eye and the Test lens in their left eye and at visit 2 was randomized to receive the Test lens in their right eye and the Control lens in their left eye. |
| FG003 | OD:Control, OS:Test/ OD:Control, OS:Test | Subjects that were randomized to receive the Control lens in their right eye and the Test lens in their left eye at both visit 1 and visit 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 |
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| Visit 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Population | All Subjects that were Fit with at least one study lens. |
| Units | Counts |
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| Participants |
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| 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 | Two-Point Light Spread Function | The two-point light spread function was assessed at visit 2 for each subject eye under two conditions with a distance filter and without a distance filter. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Two-point light spread function is defined that the as the minimum distance (mm) that two points of light are completely distinct. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and light source combination was reported across age groups. | All subjects that completed the study without a major protocol deviation impacting any primary endpoint. | Posted | Mean | Standard Deviation | mm | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2 | Eyes | Eyes |
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Throughout the entire duration of the study. One to 14 days per subject.
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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 | All subjects that wore the Test lens at either visit 1 or visit 2. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Buch, O.D. F.A.A.O - Senior Principal Research Optometrist | Johnson & Johnson Vision Care Inc. | 904-443-1707 | JBUCH@its.jnj.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 7, 2018 | Sep 17, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| senofilcon A |
| Device |
Control Lens |
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| Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1 |
| Photostress Recovery Time | Photostress Recovery (PR) Time (seconds) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects are exposed to a target, once the target was able to be comfortable viewed by the subject, a bright bleaching light covered it. As the afterimage fades, participants will gradually be able to re-gain sight of the target. PR time will be recorded as the time it takes following exposure to the bleaching light to regain sight of the target. PR Times are positive values where smaller times indicate better lens performance. The average PR Time (seconds) for each lens type was reported across age groups. | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1 |
| Glare Discomfort | The Glare discomfort (change in palpebral fissure height) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported across age groups. | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1 |
| Heterochromatic Contrast Threshold | Heterochromatic Contrast Threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Heterochromatic contrast thresholds are measured as thresholds to a variable wavelength central target presented on a short-wave (460nm) sky-light background. Thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported across age groups. | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1 |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Count of Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Subjects that wore the Test lens in either eye during visit 2. This lens was measured using an additional light source. |
| OG001 | Control With Additional Source | Subjects that wore the Control lens in either eye during visit 2. This lens was measured using an additional light source. |
| OG002 | Test Without Additional Light Source | Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source. |
| OG003 | Control Without Additional Light Source | Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source. |
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| Primary | Halos | The appearance of Halos was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Halos were quantified as the diameter (mm) of the outer edges of the Halo. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups. | All subjects that completed the study without a major protocol deviation impacting any primary endpoint. | Posted | Mean | Standard Deviation | mm | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2 | Eyes | Eyes |
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| Secondary | Glare Disability Threshold | The Glare disability threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported across age groups. | All subjects that completed the study without a major protocol deviation impacting any primary endpoint. | Posted | Mean | Standard Deviation | log units | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1 | eyes | eyes |
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| Secondary | Photostress Recovery Time | Photostress Recovery (PR) Time (seconds) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects are exposed to a target, once the target was able to be comfortable viewed by the subject, a bright bleaching light covered it. As the afterimage fades, participants will gradually be able to re-gain sight of the target. PR time will be recorded as the time it takes following exposure to the bleaching light to regain sight of the target. PR Times are positive values where smaller times indicate better lens performance. The average PR Time (seconds) for each lens type was reported across age groups. | Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint. | Posted | Mean | Standard Deviation | seconds | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1 | eyes | eyes |
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| Secondary | Glare Discomfort | The Glare discomfort (change in palpebral fissure height) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported across age groups. | Subjects that completed all study visits wihtout a major protocol deviation impacting a primary endpoint. | Posted | Mean | Standard Deviation | mm | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1 | eyes | eyes |
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| Secondary | Heterochromatic Contrast Threshold | Heterochromatic Contrast Threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Heterochromatic contrast thresholds are measured as thresholds to a variable wavelength central target presented on a short-wave (460nm) sky-light background. Thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported across age groups. | Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint. | Posted | Mean | Standard Deviation | log units | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1 | eyes | eyes |
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| Primary | Starburts | The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups. | Subjects that have completed all study visits without a major protocol deviation impacting a primary endpoint. | Posted | Mean | Standard Deviation | mm | Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2 | eyes | eyes |
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| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Control | All subjects that wore the Control lens at either visit 1 or visit 2. | 0 | 60 | 0 | 60 | 0 | 60 |
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| Eyes |
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| Linear Mixed Model Analysis | Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom. | Mean Difference (Final Values) | -24.93 | Standard Error of the Mean | 2.173 | 2-Sided | 95 | -29.24 | -20.62 | Mean difference was calculated as Test - Control | Superiority | Superiority was concluded if the upper limit of the 95% confidence interval was below 0. No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints. |
| eyes |
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| Linear Mixed Model | Linear mixed model using the Kenward and Roger method for the denominator degrees of freedom. | Mean Difference (Final Values) | -15.38 | Standard Error of the Mean | 2.555 | 2-Sided | 95 | -20.48 | -10.27 | Mean difference was calculated as Test Minus Control. | Superiority | Superiority was concluded if the upper limit of the 95% confidence interval was below 0. No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints. |