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Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses.
This is a three-arm crossover clinical evaluation of 40 subjects who will use each of three contact lens care regimens for one month with Acuvue Oasys lenses. The subjects will be randomized on the order of solutions used: Investigational MPS, ClearCare, and Opti-Free RepleniSH MPS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational MPS | Experimental | AMO Investigational MPS. |
|
| Clear Care | Active Comparator | Peroxide-based lens care regimen. |
|
| Opti-Free RepleniSH | Active Comparator | Multi-purpose disinfecting solution (Alcon). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-purpose disinfecting solution | Device | For the cleaning, rinsing, and storage of soft contact lenses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining | Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Lens Wearing Comfort | This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale. | 4 weeks |
| Dryness | This will be assessed by the tear break-up time on the lens surface, measured in seconds. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig Woods, MOptom | University of Waterloo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH 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 | Corneal Staining | Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant. | Only subjects that completed all three arms were included in analysis. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
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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 | All Participants | All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Scientist | Centre for Contact Lens Research | 519-888-4567 | 36590 | marc.schulze@uwaterloo.ca |
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| Clear Care | Device | Peroxide-based regimen for cleaning and disinfecting soft contact lenses. |
|
| Opti-Free RepleniSH | Device | Multi-purpose disinfecting solution for the cleaning, rinsing and storing of soft contact lenses. |
|
| 4 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
All subjects received the Clear Care for one month for the care of their soft contact lenses. |
| OG002 | OptiFree RepleniSH MPS | All subjects received the OptiFree RepleniSH MPS for one month for the care of their soft contact lenses. |
|
|
| Secondary | Subjective Lens Wearing Comfort | This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale. | Not Posted | 4 weeks | Participants |
| Secondary | Dryness | This will be assessed by the tear break-up time on the lens surface, measured in seconds. | Not Posted | 4 weeks | Participants |
| 0 |
| 42 |
| 0 |
| 42 |
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