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The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPTI-FREE RepleniSH | Experimental | OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days |
|
| ReNu Biotrue | Active Comparator | ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPTI-FREE RepleniSH multipurpose solution | Device | FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 | Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort. | Baseline (Day 0), Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Trial Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | OPTI-FREE RepleniSH | OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days |
| FG001 | ReNu Biotrue | ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPTI-FREE RepleniSH | OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days |
| BG001 | ReNu Biotrue | ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days |
| 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 | Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14 | Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort. | All participants who received regimen, satisfied inclusion/exclusion criteria, and completed the 14-day treatment period (per protocol) | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline (Day 0), Day 14 |
|
Adverse events were collected for the duration of the study.
The safety population includes all participants who received study regimen.
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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 | OPTI-FREE RepleniSH | OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jami Kern, Ph.D. | Alcon Global Medical Affairs | 1-888-451-3937 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ReNu Biotrue multipurpose solution | Device | FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days |
|
|
| Silicone hydrogel contact lenses | Device | Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | ReNu Biotrue | ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days |
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | ReNu Biotrue | ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days | 0 | 52 | 0 | 52 |
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