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The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcon MPDS | Experimental | MPDS used for 30 days as specified in protocol for contact lens care. |
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| renu fresh MPS | Active Comparator | MPS used for 30 days as indicated for contact lens care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID 114675A Multi-Purpose Disinfecting Solution (MPDS) | Device | Investigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses. | As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening. | As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree. | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
The Participant Flow Chart includes all randomized patients: 591. Baseline characteristics are presented for all subjects who received test article and had at least one on-regimen study visit: 578.
Subjects were recruited and enrolled from 42 US study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcon MPDS | Multi-purpose disinfecting contact lens solution |
| FG001 | Renu Fresh MPS | Multi-purpose contact lens solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| renu fresh Multi-Purpose Solution (MPS) | Device | Commercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days. |
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| Contact lenses | Device | Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis. |
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| Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses. | As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree. | Day 30 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcon MPDS | Multi-purpose disinfecting contact lens solution |
| BG001 | Renu Fresh MPS | Multi-purpose contact lens solution |
| BG002 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses. | As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree. | All enrolled and dispensed subjects with an on-regimen follow-up visit. | Posted | Mean | Standard Deviation | Units on a scale | Day 30 |
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| Secondary | Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening. | As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree. | All enrolled and dispensed subjects with an on-regimen follow-up visit. | Posted | Mean | Standard Deviation | Units on a scale | Day 30 |
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| Secondary | Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses. | As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree. | All enrolled and dispensed subjects with an on-regimen follow-up visit. | Posted | Mean | Standard Deviation | Units on a scale | Day 30 |
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Adverse events were collected for the duration of the study: 5 months, 2 weeks, 1 day.
This reporting group includes all subjects enrolled and dispensed test article.
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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 | Alcon MPDS | Multi-purpose disinfecting contact lens solution | 1 | 292 | 0 | 292 | ||
| EG001 | Renu Fresh MPS | Multi-purpose contact lens solution | 1 | 297 | 0 | 297 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizoaffective Disorder Bipolar Type | Psychiatric disorders | Systematic Assessment |
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| Abortion Spontaneous | Reproductive system and breast disorders | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 1-888-451-3937 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Male |
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