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Product performance of a Bausch & Lomb Toric Contact Lens compared to Ciba Vision Focus Daily Toric Contact Lens
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SofLens DD Toric | Experimental | Bausch & Lomb SofLens Daily Disposable Toric Contact Lens |
|
| Ciba Vision Toric Lens | Active Comparator | Ciba Vision Focus Dailies Toric Contact Lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SofLens DD Toric | Device | daily disposable wear contact lens for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms and Complaints | 1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable. | Over-all follow-up visits for 2 week period |
| Contact Lens High Contrast Visual Acuity | VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA. | Over-all follow-up visits, 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Findings | Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates | Over-all follow-up visits, 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Cairns, PhD,MCOptom | Bausch & Lomb Incorporated | Study Director |
| Benny Chian, MCOptom,DO | Laser Focus Sdn Bhd, Vision Correction Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Focus Sdn Bhd, Vision Correction Centre | Johor Bahru | 80400 | Malaysia |
220 participants were enrolled in the study, 4 participants were ineligible at screening visit, 216 Subjects started the first intervention. 211 participants started the second intervention. 209 participants completed the study.
This 4-week study was conducted at 12 sites in Asia. First participant enrolled 4/16/08, last participant visit was 6/20/08
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| ID | Title | Description |
|---|---|---|
| FG000 | SofLens DD Toric First, Then Focus Dailies Toric | Bausch & Lomb SofLens Daily Disposable Toric Contact Lens first then crossover to Ciba Vision Focus Dailies Toric Lens |
| FG001 | Focus Dailies Toric First, Then SofLens DD Toric | Ciba Vision Focus Dailies Toric Lens first, then crossover to Bausch & Lomb SofLens Daily Disposable Toric Contact Lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| |||||||||||||||||||||
| Crossover Period |
| ||||||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Population enrolled at start of study |
| 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 | Symptoms and Complaints | 1-100 Scale for each eye. Zero represented the least favorable rating and 100 represented the most favorable. | All eligible, dispensed eyes, Overall follow-up visits. | Posted | Mean | Standard Deviation | Scores on a Scale | Over-all follow-up visits for 2 week period | eyes | Participants |
|
One month
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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 | SofLens DD Toric | Bausch & Lomb SofLens Daily Disposable Toric Contact Lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Cairns, PhD, MCOptom | Bausch & Lomb Incorporated | (585) 338-5170 | gerard.cairns@bausch.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Ciba Vision Focus Dailies Toric Contact Lens |
| Device |
daily disposable wear contact lens for 2 weeks |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
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|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
|
| Secondary | Slit Lamp Findings | Graded 0-4 where 0=none and 4=severe on measure of epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates | All dispensed eyes, over all follow-up visits | Posted | Number | Eyes | Over-all follow-up visits, 2 weeks | eyes | Participants |
|
|
|
| Primary | Contact Lens High Contrast Visual Acuity | VA measures at each scheduled visit were averaged to obtain an overall measure for each eye. A non-inferiority upper bound of 0.06 (3 letters) were used to assess the difference (Test - Control) in overall logMAR VA. | All eligible, dispensed eyes | Posted | Mean | Standard Deviation | LogMAR | Over-all follow-up visits, 2 weeks | eyes | Participants |
|
|
|
| 0 |
| 215 |
| 0 |
| 215 |
| EG001 | Ciba Vision Toric Lens | Ciba Vision Focus Dailies Toric Lens | 0 | 216 | 0 | 216 |
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