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The purpose of this study was to assess comfort in soft contact lens wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPTI-FREE RepleniSH | Experimental | OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks. |
|
| Clear Care | Active Comparator | Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPTI-FREE RepleniSH multipurpose disinfecting solution | Device | FDA-approved, multipurpose disinfecting solution used according to provided instructions for cleaning, rinsing, storing, and disinfecting study contact lenses on a daily basis, 2 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Ocular Comfort Rating at 2 Weeks | 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." | Baseline (Day 0), 2 weeks |
| Likert Questionnaire Scores at 2 Weeks | The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Participants were recruited from two US study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | OPTI-FREE RepleniSH | OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks. |
| FG001 | Clear Care | Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPTI-FREE RepleniSH | OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks. |
| BG001 | Clear Care | Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks. |
| 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 in Ocular Comfort Rating at 2 Weeks | 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." | All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | Baseline (Day 0), 2 weeks |
|
Adverse events were collected for the duration of the study: 5 months, 3 weeks.
The safety population included all enrolled and exposed participants.
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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 disinfecting solution used with study contact lenses on a daily basis for 2 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jami Kern, Ph.D. | Alcon Global Medical Affairs | 1-888-451-3937 |
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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|
| Clear Care contact lens care system | Device | FDA-approved, hydrogen peroxide-based, lens care system used according to provided instructions for cleaning, disinfecting, daily protein removing, and storage of study contact lenses on a daily basis, 2 weeks. |
|
|
| Contact lenses | Device | Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Clear Care |
Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks. |
|
|
| Primary | Likert Questionnaire Scores at 2 Weeks | The Likert Questionnaire included 8 questions on selected comfort measures. All responses were recorded on a 5-point scale, where 1=Strongly Disagree, 2=Disagree, 3=Undecided, 4=Agree, and 5=Strongly Agree. | All participants who received regimen, satisfied the inclusion/exclusion criteria, and completed the 14-day treatment period, including completion of the Visit 2 evaluations. | Posted | Least Squares Mean | 95% Confidence Interval | Units on a scale | 2 weeks |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Clear Care | Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks. | 0 | 39 | 0 | 39 |
Alcon reserves the right of prior review of any publication or presentation of information related to the study.
| The solution I use feels gentle on my eyes |
|
| My lenses feel fresh |
|
| At the end of the day, my vision is clear |
|
| When I put my lenses in, they feel comfortable |
|
| I like the way this product feels during handling |
|
| My lenses feel moist |
|