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The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared to the Bausch + Lomb PureVision® soft contact lens when worn for 7-day extended wear by adapted soft contact lens wearers.
Approximately 816 participants (1,632 eyes) will be enrolled in this 12-month randomized, parallel, Investigator/Sponsor masked study at approximately 35 investigative sites in the US.
At the Screening/Dispensing Visit, approximately one-half of the participants will be randomized to receive Bausch + Lomb investigational samfilcon A soft contact lenses (Test) and approximately one-half of the subjects will be randomized to receive Bausch + Lomb PureVision soft contact lenses (Control). Both groups will wear the assigned lenses bilaterally on a 7-day extended wear basis throughout the 12 month study. The lenses are to be worn overnight for up to six consecutive nights per week. The lenses are to be removed, cleaned and disinfected on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses at the beginning of each month. Lenses will be provided at the Screening/Dispensing, 3-Month, 6-Month and 9-Month Follow-Up visits to maintain a monthly replacement schedule. Participants will also be required to complete a paper diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bausch + Lomb Samfilcon A Soft Contact Lens | Experimental | Participants will wear Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses will be worn overnight for up to 6 consecutive nights per week. The lenses will be removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses on the first monday of each month. |
|
| Bausch + Lomb Pure Vision Soft Contact Lens | Active Comparator | Participants will wear Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses will be worn overnight for up to 6 consecutive nights per week. The lenses will be removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses will be replaced with new lenses on the first monday of each month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bausch + Lomb Samfilcon A Soft Contact Lens | Device | soft contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| High Contrast Visual Acuity | For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters). | Month 12 |
| Number of Participants With Adverse Events | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section. | Baseline up to Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson Varughese | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cicero Family Eye Care | Cicero | New York | 13039 | United States |
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A total of 1632 eyes from 816 study participants were enrolled, of which 1612 eyes from 806 study participants were randomized into 1:1 to wear either the Bausch + Lomb samfilcon A soft contact lens or Bausch + Lomb pure vision soft contact lens.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bausch + Lomb Samfilcon A Soft Contact Lens | Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. |
| FG001 | Bausch + Lomb Pure Vision Soft Contact Lens | Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis set included all eligible dispensed participants under the treatment they actually received.
| ID | Title | Description |
|---|---|---|
| BG000 | Bausch + Lomb Samfilcon A Soft Contact Lens | Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. |
| 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 | High Contrast Visual Acuity | For determination of high contrast visual acuity (VA), the participant was seated at the photoropter so that the distance from the participant's eyes to the logMAR chart was 6.5 feet (2.0 meters). The chart was at eye level for each participant. The logMAR charts had two alternative letter sequences from 28 letters (0.3 logMAR) to 62 letters (-0.3 logMAR). The visual acuity was measured through the phoropter using the distance refractive correction with the addition of +0.50 Diopter to compensate for the reduced test distance of 6.5 feet (2.0 meters). A scoring sheet for each eye was provided to keep track of the letters correctly identified by the participants. Scores were recorded as the numbers of letters correctly identified in the eye examination. VA was converted to the Log10 of the Minimum Angle of Resolution (logMAR) by using the score (number of letters). | Analysis set included all eligible dispensed participants under the treatment they actually received. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | logMAR | Month 12 | eyes | eyes |
Baseline up to Month 12
Safety analysis set included all dispensed participants. Participants were analyzed as treated. AEs related to eye were only recorded by investigators and no coding dictionary was used.
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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 | Bausch + Lomb Samfilcon A Soft Contact Lens | Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral Non-Progressive Non-Infectious Corneal Ulcer | Eye disorders | No coding applied | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Bausch Health Americas, Inc. | (585) 338-5306 | Daniel.Donatello@bausch.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Bausch + Lomb Pure Vision Soft Contact Lens | Device | soft contact lenses |
|
| Chalazion upper lid |
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| Lack of motivation |
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| Unacceptable distance lens visual acuity |
|
| Military orders |
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| Participant Relocated |
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| Study related symptoms |
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| Unacceptable lens movement |
|
| Protocol Violation |
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| Physician Decision |
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| Pregnancy |
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| Withdrawal by Subject |
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| Adverse Event |
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| Randomized, not dispensed |
|
| Ineligible at Baseline |
|
| BG001 | Bausch + Lomb Pure Vision Soft Contact Lens | Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Bausch + Lomb Samfilcon A Soft Contact Lens | Participants wore Bausch + Lomb samfilcon A soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. |
| OG001 | Bausch + Lomb Pure Vision Soft Contact Lens | Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. |
|
|
| Primary | Number of Participants With Adverse Events | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse events were defined as those events that resulted in, or had the potential to cause, either permanent impairment of an ocular function or damage to an ocular structure, and might necessitate medical or surgical intervention. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in reported AE section. | Safety analysis set included all dispensed participants. | Posted | Count of Participants | Participants | Baseline up to Month 12 |
|
|
|
| 0 |
| 405 |
| 0 |
| 405 |
| 22 |
| 405 |
| EG001 | Bausch + Lomb Pure Vision Soft Contact Lens | Participants wore Bausch + Lomb pure vision soft contact lens in each eye on a 7-day extended daily wear basis for a period of 12 months. The lenses were worn overnight for up to 6 consecutive nights per week. The lenses were removed, cleaned, and disinfected with Biotrue multi-purpose solution on the seventh night and re-inserted the following morning. The lenses were replaced with new lenses on the first monday of each month. | 0 | 410 | 0 | 410 | 14 | 410 |
| Symptomatic Corneal Infiltrative Event | Eye disorders | No coding applied | Systematic Assessment |
|
| Corneal Staining greater than or equal to Grade 3 | Eye disorders | No coding applied | Systematic Assessment |
|
| Ocular Event that necessitates temporary lens discontinuation for atleast two weeks | Eye disorders | No coding applied | Systematic Assessment |
|
Please contact Sponsor directly for additional information.