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The purpose of this study was to demonstrate that current successful fulltime daily wear soft contact lens wearers using competitive multi-purpose solutions will note improved comfort when using OPTI-FREE RepleniSH®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opti-Free Replenish | Experimental | Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-Purpose Disinfecting Solution (OPTI-FREE RepleniSH) | Device | OPTI-FREE RepleniSH® used according to product labeled instructions for cleaning and disinfecting study contact lenses, 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort Ratings at Baseline | Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented. | Baseline (Day 0) |
| Comfort Ratings at 30 Days | Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
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Participants were recruited from 6 US study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Opti-Free Replenish | Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Opti-Free Replenish | Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 days. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Comfort Ratings at Baseline | Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented. | 6 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), withdrawal (3), and missing responses (1). | Posted | Number | Percentage of Participants | Baseline (Day 0) |
|
Adverse events were collected for the duration of the study: 1 month, 12 days.
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 | Multi-purpose contact lens solution for cleaning and disinfecting study contact lenses used on a daily basis for 30 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 |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Contact Lenses | Device | Contact lenses per participant's habitual prescription removed nightly for cleaning and disinfecting. |
|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Comfort Ratings at 30 Days | Prior to any ocular assessments at the visit, comfort ratings were collected on a questionnaire using 5-point Likert scale, with 1=Strongly Agree, 1=Agree, 3=Neutral, 4=Disagree, 5=Strongly Disagree. The percentage of participants responding with "Strongly Agree" or "Agree" for each question is presented. | 5 participants were excluded from analysis due to discontinuation of contact lens wear (1), treatment during study that might interfere with study outcome (1), and withdrawal (3). | Posted | Number | Percentage of Participants | 30 days |
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| 0 |
| 114 |
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| 114 |
Alcon reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Measurements |
|---|---|
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| I am satisfied with my overall lens experience |
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| Study product enhances wearing experience more |
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| I will continue to use the study solution after |
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