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This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test) lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when worn by participants who wear soft contact lens on a daily basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom Samfilcon B Contact Lenses | Experimental | Participants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS). |
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| Alden Optical HP Sphere contact lenses | Placebo Comparator | Participants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Custom Samfilcon B Contact Lenses | Device | Contact lens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Distance High-contrast logMAR Lens VA | Monocular distance high-contrast logarithm of the minimum angle of resolution (logMAR) lens visual acuity (VA) will be assessed at Week 1, Month 1, Month 2, and Month. For each eye LogMAR will be averaged at Week 1, Month 1, Month 2, and Month 3 visits, resulting in 1 value of "All Study" logMAR lens VA per eye. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion Of Eyes With Grade >2 Slit Lamp Findings | Graded slit lamp findings will be assessed at Month 3. Each eye will be classified with respect to having 1 or more observations with Grade >2 (Yes, No) at any visit. Criteria of each grade: 0=None, 1= Trace, 2= Mild, 3=Moderate, 4= Severe. Higher grades are worse outcomes. | Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
Participants who are women of childbearing potential (those who are not surgically sterilized or postmenopausal), who are currently pregnant, plan to become pregnant during the study, or are breastfeeding.
Participants who have worn gas permeable lenses in either eye within the last 30 days or who have worn polymethylmethacrylate lenses in either eye within the last 3 months.
Participants with any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health in either eye during the course of the study.
Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
Participants with an active ocular disease in either eye or who are using any ocular medication.
Participants who currently wear monovision, multifocal, or toric contact lenses in either eye.
Participants with an ocular astigmatism >1.00 D in either eye.
Participants with anisometropia (spherical equivalent) >2.00 D.
Participants with any Grade ≥2 finding in either eye during the slit lamp examination. Participants with corneal infiltrates in either eye, of any grade, are not eligible to participate in this study.
Participants with any "present" finding during the slit lamp examination in either eye that, in the Investigator's judgment, interferes with contact lens wear.
Participants with any scar or neovascularization within the central 6 millimeters (mm) of the cornea in either eye. Note: participants with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible to participate in this study.
Participants who are aphakic in either eye.
Participants who are amblyopic in either eye.
Participants who have had any corneal surgery (for example, refractive surgery) in either eye.
Participants who are allergic to any component in the study care products.
Participants who meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson Varughese | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch Site 1 | San Francisco | California | 94112 | United States | ||
| Bausch Site 2 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Custom Samfilcon B Contact Lenses | Participants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS). Custom Samfilcon B Contact Lenses: Contact lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study. |
| 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 | Jan 25, 2019 |
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| Alden Optical HP Sphere Contact Lens |
| Device |
Hioxifilcon D, 54% water, Alden Optical HP Sphere lens |
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| ReNu MultiPlus Lubricating and Rewetting Drops | Device | For use as needed during the study. |
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| Biotrue Multi-Purpose Solution | Device | For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study. |
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| Denver |
| Colorado |
| 80246 |
| United States |
| Bausch Site 3 | Sarasota | Florida | 34232 | United States |
| Bausch Site 4 | Pittsburg | Kansas | 66762 | United States |
| Bausch Site 5 | Warrensburg | Missouri | 64093 | United States |
| Bausch Site 6 | Vestal | New York | 13850 | United States |
| Bausch Site 7 | New Berlin | Wisconsin | 53151 | United States |
| FG001 | Alden Optical HP Sphere Contact Lenses | Participants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS. Alden Optical HP Sphere Contact Lens: Hioxifilcon D, 54% water, Alden Optical HP Sphere lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Custom Samfilcon B Contact Lenses | Participants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS). Custom Samfilcon B Contact Lenses: Contact lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study. |
| BG001 | Alden Optical HP Sphere Contact Lenses | Participants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS. Alden Optical HP Sphere Contact Lens: Hioxifilcon D, 54% water, Alden Optical HP Sphere lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study. |
| BG002 | Total | Total of all reporting groups |
| 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 | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of 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 | Mean Distance High-contrast logMAR Lens VA | Monocular distance high-contrast logarithm of the minimum angle of resolution (logMAR) lens visual acuity (VA) will be assessed at Week 1, Month 1, Month 2, and Month. For each eye LogMAR will be averaged at Week 1, Month 1, Month 2, and Month 3 visits, resulting in 1 value of "All Study" logMAR lens VA per eye. | Randomized participants who attended 3-month visit and had no major protocol deviations. | Posted | Mean | Standard Deviation | LogMAR | Month 3 | eyes | eyes |
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| Secondary | Proportion Of Eyes With Grade >2 Slit Lamp Findings | Graded slit lamp findings will be assessed at Month 3. Each eye will be classified with respect to having 1 or more observations with Grade >2 (Yes, No) at any visit. Criteria of each grade: 0=None, 1= Trace, 2= Mild, 3=Moderate, 4= Severe. Higher grades are worse outcomes. | Posted | Count of Units | eyes | Month 3 | eyes | eyes |
|
3 months
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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 | Custom Samfilcon B Contact Lenses | Participants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS). Custom Samfilcon B Contact Lenses: Contact lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study. | 0 | 56 | 0 | 56 | 0 | 56 |
| EG001 | Alden Optical HP Sphere Contact Lenses | Participants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS. Alden Optical HP Sphere Contact Lens: Hioxifilcon D, 54% water, Alden Optical HP Sphere lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study. | 0 | 28 | 0 | 28 | 0 | 28 |
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Please contact sponsor for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johnson Varughese | Bausch & Lomb | 9089271162 | Johnson.Varughese@bauschhealth.com |
| May 4, 2022 |
| Prot_SAP_000.pdf |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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