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The objective of this study is to determine the clinical feasibility and to evaluate the product performance of two RD2135-01 investigational soft contact lenses (Test 1 and Test 2) developed by Bausch + Lomb. The Test lenses will be compared to both Bausch + Lomb PureVision®2 HD (high definition) soft contact lenses and Ciba Vision Air Optix Aqua soft contact lenses when used among currently adapted soft contact lens wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B&L RD2135-01 lens C | Experimental | Investigational Silicone hydrogel soft contact lens |
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| B&L RD2135-01 lens D | Experimental | Investigational Silicone hydrogel soft contact lens |
|
| PureVision2 | Active Comparator | Bausch & Lomb High definition soft contact lenses |
|
| Ciba Vision Air Optix Aqua | Active Comparator | Ciba Vision Air Optix Aqua soft contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B&L RD2135-01 lens C | Device | Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | At 1 week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms and Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded for each eye based on the participant's experience with their study lenses worn for that respective treatment period. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, Lens cleanness, Dryness at end of day, and Overall impression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly J Barna, CCRA | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Rochester | New York | 14609 | United States |
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This was a randomized, bilateral, study, with a crossover at one week and a second crossover at two weeks. A total of 216 subjects (432 eyes) were enrolled in this study. Participants were randomized to receive either, the Test Lens C, Test Lens D and PureVision2 lenses, or the Test Lens C, Test Lens D and Air Optix Aqua lenses.
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| ID | Title | Description |
|---|---|---|
| FG000 | B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then PureVision | B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then PureVision2 for one week |
| FG001 | B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then Ciba Vis | B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then Ciba Vision for one week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demography was collected for 210 eligible, dispensed participants. Participants received multiple treatment groups in this cross-over study. Two participants did not have demography information.
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| ID | Title | Description |
|---|---|---|
| BG000 | B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then PureVision | B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then PureVision2 for one week |
| BG001 | B&L RD2135-01 Lens C Then B&L RD2135-01 Lens D Then Ciba Vis |
| 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 | Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | There were 212 eligible, dispensed participants (424 eyes). Participants/eyes received multiple treatment groups in this cross-over study. All eyes received investigational lens C and investigation lens D. Half of the eyes received PureVision2 and half of the eyes received Ciba Vision Air Optix Aqua. | Posted | Mean | Standard Deviation | logMAR | At 1 week follow up | eyes | eyes |
|
3 weeks
Adverse events (AEs) were not coded. Therefore, source vocabulary is not applicable. Safety data were collected for 212 eligible, dispensed participants. Participants received multiple treatment groups in this cross-over study.
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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 | B&L RD2135-01 Lens C | B&L RD2135-01 Lens C |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | robert.steffen@bausch.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| B&L RD2135-01 lens D | Device | Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. |
|
| PureVision2 | Device | Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. |
|
| Air Optix Aqua | Device | Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. |
|
| At 1 Week follow up |
B&L RD2135-01 Lens C for one week then B&L RD2135-01 Lens D for one week then Ciba Vision for one week |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | B&L RD2135-01 Lens D | Investigational Silicone hydrogel soft contact lens B&L RD2135-01 lens D: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. |
| OG002 | PureVision2 | Bausch & Lomb High definition soft contact lenses PureVision2: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. |
| OG003 | Ciba Vision Air Optix Aqua | Ciba Vision Air Optix Aqua soft contact lens Air Optix Aqua: Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study. |
|
|
| Secondary | Symptoms and Complaints | Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. Symptoms/complaints were recorded for each eye based on the participant's experience with their study lenses worn for that respective treatment period. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, Lens cleanness, Dryness at end of day, and Overall impression. | There were 212 eligible, dispensed participants (424 eyes). Participants/eyes received multiple treatment groups in this cross-over study. All eyes received investigational lens C and investigation lens D. Half of the eyes received PureVision2 and half of the eyes received Ciba Vision Air Optix Aqua. | Posted | Least Squares Mean | Standard Deviation | score on a scale | At 1 Week follow up | eyes | eyes |
|
|
|
| 0 |
| 212 |
| 0 |
| 212 |
| EG001 | B&L RD2135-01 Lens D | B&L RD2135-01 Lens D | 0 | 212 | 0 | 212 |
| EG002 | PureVision2 | PureVision2 | 0 | 106 | 0 | 106 |
| EG003 | Ciba Vision Air Optix Aqua | Ciba Vision Air Optix Aqua | 0 | 106 | 0 | 106 |
Contact sponsor directly for details.
| eyes |
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| Comfort upon insertion |
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| Overall comfort |
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| Comfort at end of day |
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| Ease of handling/insertion |
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| Ease of handling/removal |
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| Dryness |
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| Itchiness |
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| Redness |
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| Vision upon insertion |
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| Vision |
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| Vision in low light |
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| Lens cleanness upon insertion |
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| Lens cleannes upon removal |
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| Lens cleanness |
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| Dryness at end of day |
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| Overall impression |
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