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The objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silicone Hydrogel Contact Lens | Experimental | Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silicone Hydrogel Contact Lens | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use? | Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses | 7 days |
| Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long. | Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses deliver exceptional clarity and comfort all day long." Prefer study lenses Prefer usual lenses About the same as usual lenses | 7 days |
| Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes. | Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses help maintain healthy, white eyes." Prefer study lenses Prefer usual lenses About the same as usual lenses | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Performance Assessment | High Contrast Distance logMAR Lens VA Change From Baseline to Week 2. | 2 weeks |
| Any Graded Slit Lamp Finding > 2 | Slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson Varughese | Valeant Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Madison | New Jersey | 07940 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Silicone Hydrogel Contact Lens | Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses. Silicone Hydrogel Contact Lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Eligible participants dispensed lenses
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| ID | Title | Description |
|---|---|---|
| BG000 | Silicone Hydrogel Contact Lens | Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses. Silicone Hydrogel Contact Lens |
| 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 | Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use? | Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses | There were 380 eligible subjects with lenses dispensed. | Posted | Count of Participants | Participants | 7 days |
|
2 weeks
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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 | Silicone Hydrogel Contact Lens | Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses. Silicone Hydrogel Contact Lens |
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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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| 2 weeks |
| 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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| Primary | Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long. | Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses deliver exceptional clarity and comfort all day long." Prefer study lenses Prefer usual lenses About the same as usual lenses | There were 380 eligible subjects with lenses dispensed. | Posted | Count of Participants | Participants | 7 days |
|
|
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| Primary | Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes. | Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses help maintain healthy, white eyes." Prefer study lenses Prefer usual lenses About the same as usual lenses | There were 380 eligible subjects with lenses dispensed. | Posted | Count of Participants | Participants | 7 days |
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| Secondary | Lens Performance Assessment | High Contrast Distance logMAR Lens VA Change From Baseline to Week 2. | High contrast distance lens visual acuity (VA) was assessed at Screening/Dispensing on the Test (newly dispensed) lenses, and at the follow-up visit(s). The population included subjects with baseline and at least one post-baseline assessment. | Posted | Mean | Standard Deviation | Log of Minimum Angle of Resolution VA | 2 weeks | Eyes | Eyes |
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| Secondary | Any Graded Slit Lamp Finding > 2 | Slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade. | Percentages are based on the number of dispensed eyes with non-missing scores. | Posted | Count of Units | Eyes | 2 weeks | Eyes | Eyes |
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| 0 |
| 396 |
| 0 |
| 396 |
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