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Evaluation of Johnson & Johnson Acuvue Vita (senofilcon C) soft contact lenses to the Bausch + Lomb Ultra (samfilcon A) soft contact lenses
to compare the performance of currently marketed Johnson & Johnson Acuvue Vita (senofilcon C) soft contact lenses to the currently marketed Bausch + Lomb Ultra (samfilcon A) soft contact lenses among adapted wearers of Acuvue Oasys soft contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Senofilcon C | Experimental | Senofilcon C Contact Lens |
|
| Samfilcon A | Experimental | Samfilcon A Contact Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Senofilcon C | Device | Senofilcon C Contact Lens |
| |
| Samfilcon A |
| Measure | Description | Time Frame |
|---|---|---|
| End of Day Comfort | The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort. | 1 month |
| Overall Vision | The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated better overall vision. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation
Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:
Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| valeant Site 02 | San Diego | California | 92123 | United States | ||
| Valeant Site 03 |
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There were 271 participants enrolled, with 136 Senofilcon C participants dispensed lenses and 132 Samfilcon A participants dispensed lenses (268 participants total).
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon C | Senofilcon C Contact Lens Senofilcon C: Senofilcon C Contact Lens |
| FG001 | Samfilcon A | Samfilcon A Contact Lens Samfilcon A: Samfilcon A Contact Lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants that completed all study visits without a major protocol deviation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Senofilcon C | Senofilcon C Contact Lens Senofilcon C: Senofilcon C Contact Lens |
| BG001 | Samfilcon A | Samfilcon A Contact Lens Samfilcon A: Samfilcon A Contact Lens |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | End of Day Comfort | The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated greater comfort. | All participants that completed all study visits without a major protocol deviation. | Posted | Median | Standard Deviation | score on a scale | 1 month |
|
1 month
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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 | Senofilcon C | Senofilcon C Contact Lens Senofilcon C: Senofilcon C Contact Lens |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal infiltrates | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | +1 (585) 338-6399 | Robert.Steffen@bausch.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 | Aug 29, 2017 | Aug 27, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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randomized, bilateral, d o u b l e - masked, 1-month study with two parallel groups
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| Device |
Samfilcon A Contact Lens |
|
| San Francisco |
| California |
| 94112 |
| United States |
| Valeant Site 04 | Denver | Colorado | 80246 | United States |
| Valeant Site 06 | Orlando | Florida | 32803 | United States |
| Valeant Site 01 | Orlando | Florida | 32812 | United States |
| Valeant Site 05 | Sarasota | Florida | 34232 | United States |
| Valeant Site 07 | Pittsburg | Kansas | 66762 | United States |
| Valeant Site 08 | Warrensburg | Missouri | 64093 | United States |
| Valeant Site 09 | Vestal | New York | 13850 | United States |
| Valeant Site 10 | Powell | Ohio | 43065 | United States |
| Valeant Site 11 | New Berlin | Wisconsin | 53151 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Overall Vision | The 100 point , take home questionnaire evaluated performance of the lenses based on subject responses. Possible scores were 0-100. Higher scores indicated better overall vision. | All participants that completed all study visits without a major protocol deviation. | Posted | Median | Standard Deviation | score on a scale | 1 month |
|
|
|
| 0 |
| 136 |
| 0 |
| 136 |
| 0 |
| 136 |
| EG001 | Samfilcon A | Samfilcon A Contact Lens Samfilcon A: Samfilcon A Contact Lens | 0 | 132 | 0 | 132 | 1 | 132 |
Contact sponsor directly for details.