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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.
The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase1 - Arm 1 | Active Comparator |
| |
| Phase1 - Arm 2 | Active Comparator |
| |
| Phase 2 - Arm 1 | Active Comparator |
| |
| Phase 2 - Arm 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcon Opti-Free® RepleniSH® with Supraclens® | Drug | Marketed Multipurpose Disinfecting Care System + Marketed contact lens protein remover |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'. | 4 weeks |
| Lens Wettability | Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced). | 4 weeks |
| Lens Deposits | Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dryness | Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'. | 4 weeks |
| Subjective Vision | Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Desmond Fonn, MOptom | University of Waterloo | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research, School of Optometry, University of Waterloo. | Waterloo | Ontario | N2L3G1 | Canada |
Phase 1 - 38 participants enrolled, Phase 2 - 38 participants enrolled. For both Phase 1 and 2 a washout period of at least one day, during which time participants wore spectacles and no contact lenses.
Recruitment started January 2008 at CCLR (Study completed July 2008)
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| ID | Title | Description |
|---|---|---|
| FG000 | Ph1: 1st-RepleniSH(No-rub) & Supraclens, 2nd RepleniSH(Rub) | Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and Alcon RepleniSH™ 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study. |
| FG001 | Ph1: 1st-RepleniSH(Rub), 2nd-RepleniSH(No-rub) & Supraclens | Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study. |
| FG002 | Ph2: 1st-RepleniSH(No-rub)&Supraclens, 2nd ReNUMultiplus(Rub) | Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) first, and B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study. |
| FG003 | Ph2: 1st-ReNu Multiplus(Rub), 2nd RepleniSH(No-rub)&Supraclens | Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' first, and Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) second. Participants wore PureVision lenses on a daily wear basis for at least eight to ten hours per day and at least six days per week for the duration of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention for Phase1&Phase2 |
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| Second Intervention for Phase1&Phase2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ph1: RepleniSH(No-rub) & Supraclens | Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group. |
| BG001 | Ph1: RepleniSH(Rub) |
| 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, 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 | Comfort | Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'. | analysis was per protocol | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
One business day to Office of Research Ethics
No adverse events were reported for this study.
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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 | Ph1: RepleniSH(No-rub) & Supraclens | Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Craig A Woods, Research Manager | Centre for Contact Lens Research | 1 519 888 4567 | 36547 | cawoods@sciborg.uwaterloo.ca |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Alcon Opti-Free® RepleniSH® | Drug | Marketed Multipurpose Disinfecting Care System |
|
| B&L ReNu MultiPlus™ | Drug | Marketed Multipurpose Disinfecting Care Systems |
|
| 4 weeks |
| Corneal Staining | Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent. Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions. A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining. | 4 weeks |
| COMPLETED |
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| NOT COMPLETED |
|
|
Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group.
| BG002 | Ph2: RepleniSH(No-rub) & Supraclens | Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group. |
| BG003 | Ph2: ReNu Multiplus(Rub) | Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Ph2: RepleniSH(No-rub) & Supraclens | Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group. |
| OG003 | Ph2: ReNu Multiplus(Rub) | Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group. |
|
|
| Secondary | Dryness | Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'. | analysis was per protocol | Posted | Feb 2010 | Mean | Standard Deviation | Units on a Scale | 4 weeks |
|
|
|
| Secondary | Subjective Vision | Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'. | analysis was per protocol | Posted | Feb 2010 | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| Secondary | Corneal Staining | Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent. Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions. A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining. | analysis was per protocol | Posted | Feb 2010 | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| Primary | Lens Wettability | Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced). | analysis was per protocol | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| Primary | Lens Deposits | Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits). | analysis was per protocol | Posted | Mean | Standard Deviation | Units on a scale | 4 weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Ph1: RepleniSH(Rub) | Phase 1 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group. | 0 | 0 | 0 | 0 |
| EG002 | Ph2: RepleniSH(No-rub) & Supraclens | Phase 2 - Alcon RepleniSH™ (Contact lens cleaning and disinfecting solution) with 'no lens rub' and Supraclens® (Daily protein remover) group. | 0 | 0 | 0 | 0 |
| EG003 | Ph2: ReNu Multiplus(Rub) | Phase 2 - B&L ReNu MultiPlus™ (Contact lens cleaning and disinfecting solution) 'with lens rub' group. | 0 | 0 | 0 | 0 |
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