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The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bausch & Lomb Test Lens | Experimental | Bausch + Lomb investigational soft contact lens |
|
| Ciba Vision soft contact lens | Active Comparator | Ciba Vision Air Optix Aqua soft contact lens |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bausch & Lomb Test lens | Device | Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups. | One week |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Comfort | The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score. | One week |
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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 |
100 participants (200 eyes) were enrolled in this 2 week crossover study. Participants were divided into 2 groups wearing one study lens for 1 week and then crossing over to the other study lens for 1 week. 96 participants completed the study, 1 participant was ineligible at baseline while 3 participants were discontinued during the study.
This study was conducted at 5 clinical sites in the US. First participant was enrolled 08/08/2011 and last participant exited on 09/01/2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bausch+Lomb Test Lens Then Ciba Vision Lens | Bausch+Lomb investigational soft contact lens Bausch+Lomb Test lens:Ciba Vision Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses. |
| FG001 | Ciba Vision Soft Contact Lens Then Bausch+Lomb Test Lens | Ciba Vision Air Optix Aqua soft contact lens Ciba Vision lens:Bausch+Lomb Test Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Period |
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| 2nd Period |
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All participants enrolled in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All 99 participants in study |
| 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 | The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups. | All eligible dispensed eyes | Posted | Least Squares Mean | Standard Deviation | LogMAR | One week | eyes | Participants |
|
1 week
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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 Test Lens | Bausch + Lomb investigational soft contact lens Bausch & Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Steffen | Bausch & Lomb | 1 585 338 6399 | robbert.steffen@bausch.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Ciba Vision soft contact lens | Device | Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses. |
|
| Unacceptable lens movement |
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| Inability to maintain wear |
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| NOT COMPLETED |
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| 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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| Region of Enrollment | Number | participants |
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| Secondary | Overall Comfort | The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score. | All eligible dispensed eyes | Posted | Least Squares Mean | Standard Deviation | units on a scale | One week | Eyes | Participants |
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| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | Ciba Vision Soft Contact Lens | Ciba Vision Air Optix Aqua soft contact lens Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses. | 0 | 99 | 0 | 99 |
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