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The objective of this 2 hour study is to evaluate the clinical performance of samfilcon A lenses with an alternate packaging solution (EPG01) compared to commercially available B+L Ultra lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Samfilcon A Lenses with EPG01 Packaging Solution | Experimental | Subjects implanted with Samfilcon A Lenses with EPG01 Packaging Solution |
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| Commercially Available B+L Ultra Lenses | Active Comparator | Subjects implanted with Commercially Available B+L Ultra Lenses |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| samfilcon A Lenses with EPG01 Packaging Solution | Device | samfilcon A Lenses with EPG01 Packaging Solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Normalized logMAR Visual Acuity | Normalized logMAR visual acuity is the change in visual acuity (how well you can see) from baseline (spectacle). Normalized visual acuity is calculated by subtracting the logMAR visual acuity with a contact lens from the baseline (refraction without a contact lens). Each letter on the logMAR visual acuity chart has a value of 0.02. | Assessed at 2-hour post-baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffery Schafer, OD | Bausch & Lomb Incorporated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch and Lomb Site 01 | Rochester | New York | 14609 | United States |
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This is a contralateral study. 30 subjects were enrolled and were dispensed lenses based on a randomization schedule.
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| ID | Title | Description |
|---|---|---|
| FG000 | Samfilcon A Lenses With EPG01 Packaging Solution and Commercially Available B+L Ultra Lenses. | Each participant wore the test lens in one eye and the control lens in the fellow eye for 2 hours. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 13, 2021 |
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| Commercially Available B+L Ultra Lenses | Device | Commercially Available B+L Ultra Lenses |
|
| Samfilcon A Lenses With EPG01 Packaging Solution |
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| B+L Ultra Lenses |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Samfilcon A Lenses With EPG01 Packaging Solution and Commercially Available B+L Ultra Lenses. | Participants were implanted with both samfilcon A Lenses with EPG01 Packaging Solution and commercially available B+L Ultra lenses. |
| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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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 | Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Number | participants | Participants |
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| 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 | Normalized logMAR Visual Acuity | Normalized logMAR visual acuity is the change in visual acuity (how well you can see) from baseline (spectacle). Normalized visual acuity is calculated by subtracting the logMAR visual acuity with a contact lens from the baseline (refraction without a contact lens). Each letter on the logMAR visual acuity chart has a value of 0.02. | Posted | Mean | Standard Deviation | LogMAR units | Assessed at 2-hour post-baseline | Lenses | Lenses |
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Assessed at 2-hour post-baseline
There were no adverse events with the samfilcon A lenses with EPG01 packaging solution.
There were no adverse events with the commercially available. B+L Ultra lenses.
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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 | Samfilcon A Lenses With EPG01 Packaging Solution and Commercially Available B+L Ultra Lenses. | Participants wore samfilcon A lens with EPG01 in one eye and a commercially available B+L Ultra lens in the fellow eye | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Schafer, Jill | Bausch + Lomb Incorporated | 0000000 | Jill.Schafer@bausch.com |
| Nov 8, 2022 |
| Prot_SAP_000.pdf |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
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| Female |
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| Male |
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| Title | Measurements |
|---|---|
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