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The objective of this clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in Control, solution as it relates to comfort when used by subjects who use technology devices (eg, Personal Digital Assistants [PDAs], computers, electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an average of 4 hours per day over a week's time for a minimum of 4 days each week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental- Soflens | Experimental | Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. |
|
| Marketed - Soflens | Active Comparator | Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental- Soflens | Device | A new pair of lenses will be worn each day while the subject is in the study |
|
| 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. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Initial Lens Performance Survey | A lens performance survey was given to each participant at the Screening/Dispensing Visit, three minutes following insertion of the study lenses. Lens performance was assessed by eye for the following parameters: burning/stinging upon insertion, comfort upon insertion, ease of handling/insertion, vision upon insertion, and lens cleanness upon insertion. As with symptoms/complaints, responses were on a scale from 0 to 100, with 0 being the most unfavorable score. |
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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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There were 441 participants (882 eyes) enrolled, 221 in the test group and 220 in the control group. There were 434 eligible participants (868 eyes) who participated in the study, 216 in the test group and 218 in the control group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental- Soflens | Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study |
| FG001 | Marketed - Soflens | Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Eligible, dispensed participants were summarized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental- Soflens | Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study |
| BG001 | Marketed - Soflens |
| 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. | There were 438 eyes in the test group and 434 eyes in the control group that were assessed for this outcome measure. | Posted | Count of Units | eyes | 2 weeks | eyes | eyes |
|
2 weeks
Adverse events were not coded. Therefore, source vocabulary is not applicable.There were 440 eyes dispensed test lenses and 436 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 | Experimental- Soflens | Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution. Experimental- Soflens: A new pair of lenses will be worn each day while the subject is in the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 908-300-9920 | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Marketed - Soflens | Device | A new pair of lenses will be worn each day while the subject is in the study. |
|
| At dispensing |
Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Marketed - Soflens | Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study. |
|
|
| Secondary | Initial Lens Performance Survey | A lens performance survey was given to each participant at the Screening/Dispensing Visit, three minutes following insertion of the study lenses. Lens performance was assessed by eye for the following parameters: burning/stinging upon insertion, comfort upon insertion, ease of handling/insertion, vision upon insertion, and lens cleanness upon insertion. As with symptoms/complaints, responses were on a scale from 0 to 100, with 0 being the most unfavorable score. | There were 426 eyes in the test group and 424 eyes in the control group that were assessed for this outcome measure. | Posted | Least Squares Mean | Standard Deviation | score on a scale | At dispensing | eyes | eyes |
|
|
|
| 0 |
| 221 |
| 0 |
| 221 |
| EG001 | Marketed - Soflens | Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution. Marketed - Soflens: A new pair of lenses will be worn each day while the subject is in the study. | 0 | 220 | 0 | 220 |
Contact sponsor directly for details.
| Ease of Handling/Insertion |
|
| Vision Upon Insertion |
|
| Lens Cleanness Upon Insertion |
|