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This study is being conducted to evaluate the product performance of SofLens daily disposable contact lenses packaged in an investigational Test solution versus SofLens daily disposable contact lenses packaged in the currently marketed solution (Control), as it relates to comfort when worn by adapted soft contact lens wearers on a daily-wear basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SofLens in investigational solution | Experimental | Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. |
|
| SofLens in currently marketed solution | Active Comparator | SofLens daily disposable contact lens packaged in currently marketed storage solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SofLens in investigational solution | Device | SofLens in investigational solution, worn on a daily disposable basis for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With > Grade 2 Slit Lamp Findings | Graded 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). The outcome measure is any finding > grade 2, across abnormalities. | At 2 weeks follow up |
| Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | At 2 weeks follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms and Complaints | Symptoms and complaints were assessed on a scale from 0 to 100, with 0 denoting the most unfavorable symptoms/complaints. Symptoms/complaints were collected by eye from each participant and based on the participant's experience with the study lenses. 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, and Overall impression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb, Inc. | Rochester | New York | 14609 | United States |
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There were 438 eligible participants (876 eyes) enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | SofLens in Investigational Solution | Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days. |
| FG001 | SofLens in Currently Marketed Solution | SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demographics were reported for all dispensed, eligible participants, 222 in the investigational group and 215 in the control group.
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| ID | Title | Description |
|---|---|---|
| BG000 | SofLens in Investigational Solution | Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days. |
| BG001 | SofLens in Currently Marketed Solution |
| 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 | Percentage of Eyes With > Grade 2 Slit Lamp Findings | Graded 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). The outcome measure is any finding > grade 2, across abnormalities. | Dispensed eyes with nonmissing scores in each treatment group are included in the analysis population. | Posted | Count of Units | eyes | At 2 weeks follow up | eyes | eyes |
|
6 weeks
Adverse events were not coded. Therefore, source vocabulary is not applicable. There were 444 eyes dispensed test lenses and 432 eyes dispensed control lenses, assessed for adverse events.
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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 in Investigational Solution | Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution. SofLens in investigational solution: SofLens in investigational solution, worn on a daily disposable basis for 7 days. |
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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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| SofLens in currently marketed solution | Device | SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days. |
|
| At 2 weeks follow up |
SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | SofLens in Currently Marketed Solution | SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days. |
|
|
| Primary | Visual Acuity | Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR). | Eyes assessed for visual acuity at the 2 week follow up visit are included in the analysis population. | Posted | Least Squares Mean | Standard Deviation | logMAR | At 2 weeks follow up | eyes | eyes |
|
|
|
| Secondary | Symptoms and Complaints | Symptoms and complaints were assessed on a scale from 0 to 100, with 0 denoting the most unfavorable symptoms/complaints. Symptoms/complaints were collected by eye from each participant and based on the participant's experience with the study lenses. 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, and Overall impression. | Eyes assessed for symptoms/complaints at the 2 week follow up visit are included in the analysis population. | Posted | Least Squares Mean | Standard Deviation | score on a scale | At 2 weeks follow up | eyes | eyes |
|
|
|
| 0 |
| 222 |
| 0 |
| 222 |
| EG001 | SofLens in Currently Marketed Solution | SofLens daily disposable contact lens packaged in currently marketed storage solution. SofLens in currently marketed solution: SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days. | 0 | 216 | 0 | 216 |
Contact sponsor directly for details.
| Overall comfort |
|
| 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 |
|
| Redness |
|
| Vision upon insertion |
|
| Vision |
|
| Vision in low light |
|
| Lens cleanness upon insertion |
|
| Lens cleanness upon removal |
|
| Overall impression |
|