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The objective of this one week, single group, bilateral, open-label study is to evaluate the product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test) when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted soft contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prism I | Experimental | Bausch & Lomb daily disposable cosmetic tint contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily disposable cosmetic tint lens | Device | Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Market Research Survey | Online subjective assessments that subjects responded to after wearing the study lenses for at least one week. Subjects were asked to rate their overall opinion as: Excellent, Very Good, Good, Fair, or Poor. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Evaluation - Centration | To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens centration, meaning the lens should provide full corneal coverage, was assessed during the slit lamp evaluation. Findings were reported as: Excellent, Good, Fair, or Poor. | Over all study visits through 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Singapore | 556741 | Singapore |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prism I | Bausch & Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Demographics are reported for all eligible, dispensed subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prism I | Bausch & Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week. |
| 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, 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 | Market Research Survey | Online subjective assessments that subjects responded to after wearing the study lenses for at least one week. Subjects were asked to rate their overall opinion as: Excellent, Very Good, Good, Fair, or Poor. | Subjects who completed the survey. | Posted | Count of Participants | Participants | 1 week |
|
|
Up to 1 week
Adverse events were collected throughout the 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 | Prism I | Bausch & Lomb daily disposable cosmetic tint contact lens Daily disposable cosmetic tint lens: Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Steffen | Bausch Health Americas, Inc | Robert.Steffen@bausch.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Lens Evaluation - Movement | To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens movement, meaning the lens should provide discernible movement with:
| Over all study visits through 1 week |
| Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA). | For determination of high contrast VA, the subject was to be seated so that the distance from the subject's eyes to the logMAR chart is 6.5 feet (2.0 meters). The chart should be at eye level for the subject. The logMAR charts have two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity should be measured through the phoropter using the distance refractive correction with the addition of +0.50D to compensate for the reduced test distance of 6.5 feet (2.0 meters). | Over all study visits for 1 week |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Lens Evaluation - Centration | To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens centration, meaning the lens should provide full corneal coverage, was assessed during the slit lamp evaluation. Findings were reported as: Excellent, Good, Fair, or Poor. | Eligible, dispense eyes with non-missing scores. | Posted | Count of Units | eyes | Over all study visits through 1 week | eyes | eyes |
|
|
|
| Secondary | Lens Evaluation - Movement | To determine proper lens parameters the lens relationship to the eye was observed using a slit lamp. Lens movement, meaning the lens should provide discernible movement with:
| Eligible, dispense eyes with non-missing scores. | Posted | Count of Units | eyes | Over all study visits through 1 week | eyes | eyes |
|
|
|
| Secondary | Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA). | For determination of high contrast VA, the subject was to be seated so that the distance from the subject's eyes to the logMAR chart is 6.5 feet (2.0 meters). The chart should be at eye level for the subject. The logMAR charts have two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity should be measured through the phoropter using the distance refractive correction with the addition of +0.50D to compensate for the reduced test distance of 6.5 feet (2.0 meters). | Eyes with VA results | Posted | Mean | Standard Error | logMAR | Over all study visits for 1 week | eyes | eyes |
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| 0 |
| 212 |
| 0 |
| 212 |
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| Poor |
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| Adherence |
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