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The purpose of this study is to determine if Alcon MPDS is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.
The purpose of this study is to determine if Alcon Multi-Purpose Disinfecting Solution (MPDS) is safe and effective for silicone hydrogel and soft hydrogel contact lens wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alcon MPDS | Experimental | Alcon Multi-Purpose Disinfecting Solution (MPDS) |
|
| ReNu Fresh Multi-Purpose Solution | Active Comparator | ReNu Fresh Multi-Purpose Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcon MPDS | Device | Multi-Purpose Solution intended for use with silicone hydrogel and soft contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Acceptance | Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree) | Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessie M Lemp, MS | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alcon MPDS | Alcon Multi-Purpose Disinfecting Solution (MPDS) |
| FG001 | ReNu Fresh Multi-Purpose Solution | ReNu Fresh Multi-Purpose Solution (MPS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Alcon MPDS | Alcon Multi-Purpose Disinfecting Solution (MPDS) |
| BG001 | ReNu Fresh Multi-Purpose Solution | ReNu Fresh Multi-Purpose Solution (MPS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Subjective Acceptance | Lens Moisture Subject Rated Likert Item (1-Strongly Agree to 5-Strongly Disagree) | Posted | Mean | Standard Deviation | units on a scale | Day 90 |
|
|
AE Forms document adverse events during study(occurring after exposure to test article), causality assessment performed by investigator/sponsor. A SAE Form completed & forwarded to Alcon/IRB/EC 24 hours of investigator's knowledge of event
AE Forms document all AEs that occur during study (occurring after exposure to test article), causality assessment performed by investigator/sponsor. A SAE Form completed for all SAEs, forwarded to Alcon/IRB/EC within 24 hours of the investigator's knowledge of the event according to their requirements.
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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 | Alcon Multi-Purpose Disinfecting Solution (MPDS) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (version 12.0 | Unrelated to Test Article |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ReNu Fresh MPS | Device | ReNu Fresh MPS is a marketed product indicated for cleaning, removing protein deposits, rinsing, disinfecting and storage of soft contact lenses. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 288 |
| 0 |
| 288 |
| EG001 | ReNu Fresh Multi-Purpose Solution | ReNu Fresh Multi-Purpose Solution (MPS) | 1 | 285 | 0 | 285 |
All data and discoveries arising out of the Study shall be the sole property of Alcon or its designated affiliate. Alcon reserves the right of prior review of any publication or presentation of the information related to the Study.