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This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test lens | Experimental | Test contact lens will be worn on a daily disposable wear basis. |
|
| SofLens lens | Active Comparator | The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test, daily disposable contact lens | Device | Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. |
| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Findings > Grade 2 | Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses | 4 visits over 3 months |
| High Contrast, Distance logMAR Visual Acuity (VA) | Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint | 4 visits over 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Barna, CCRA | Bausch & Lomb Incorporated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb, Inc. | Rochester | New York | 14609 | United States |
This was a 3 month randomized, parallel, bilateral, single-masked study. One participant discontinued the study.
A total of 173 participants (346 eyes) were enrolled at 11 investigative sites in the United States (US), the first participant was enrolled in the study on 6/13/2011, the last participant exited the study on 10/1/2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | SofLens Lens | The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. |
| FG001 | Test Lens | Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SofLens | The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Slit Lamp Findings > Grade 2 | Statistical non-inferiority of Slit Lamp Findings > Grade 2 at any visit between the Test and Control lenses | Over All Follow-up Visits, Eyes with Findings > Grade 2 (All Dispensed Eyes) | Posted | Number | eyes | 4 visits over 3 months | eyes | Participants |
|
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 | SofLens Lens | The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis. SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Steffen, OD, MS | Bausch & Lomb Incorporated | (585) 338-6399 | robert.steffen@bausch.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| SofLens daily disposable contact lens | Device | Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. |
|
| BG001 | Test Lens | Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. |
|
|
| Primary | High Contrast, Distance logMAR Visual Acuity (VA) | Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint | All Eligible, Dispensed Eyes | Posted | Mean | Standard Deviation | logMAR | 4 visits over 3 months | eyes | Participants |
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | Test Lens | Test contact lens will be worn on a daily disposable wear basis. Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality. | 0 | 87 | 0 | 87 |
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