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Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).
To determine if patients are unreactive to the lens care solution / Biofinity combination. It is expected that there will be a total of three visits: V1 (Initial), V2 (1 week), & V3 (2 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioclean MPS VII / comfilcon A combination | Active Comparator | Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study. |
|
| Aosept Clearcare / comfilcon A combination | Active Comparator | Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioclean MPS VII | Device | PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Health - Corneal Staining | Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort | Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuji Kodama, MD, PhD | Kodama Eye Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kodama Eye Clinic | Joyo-shi | Kyoto | 610-0121 | Japan | ||
| Higashihara Eye Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bioclean MPS VII Combo, Then Aosept Clearcare Combo | Participants were randomized to the Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination for one week, then cross over to the alternative Aosept Clearcare / comfilcon A combination Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system comfilcon A: contact lens |
| FG001 | Aosept Clearcare Combo, Then Bioclean MPS VII Combo | Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week then cross over to the alternative Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination. Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system comfilcon A: contact lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Days) |
| |||||||||||||
| Second Intervention (7 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Participants | Participants were randomized to the Bioclean MPS VII / comfilcon A combination or Aosept Clearcare / comfilcon A combination for one week, then cross over to the alternative combination. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Ocular Health - Corneal Staining | Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp. Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe. | Posted | Number | Eyes | 1 week | Eyes | Eyes |
|
From dispense up to two weeks for each study lenses
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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 | Bioclean MPS VII / Comfilcon A Combination | Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study. Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system comfilcon A: contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Professional Services Organization | Coopervision Japan | 81-3-5449-6619 | taku.muraoka@jp.coopervision.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Aosept Clearcare | Device | Hydrogen Peroxide Disinfecting and Cleaning system |
|
| comfilcon A | Device | contact lens |
|
|
| Dryness |
Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent. |
| 1 week |
| Stinging and Burning Sensation | Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all. | Baseline |
| Kameoka |
| Kyoto |
| 621-0861 |
| Japan |
| Iwasaki Eye Clinic | Osaka | Osaka | 542-0082 | Japan |
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Comfort | Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Dryness | Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear. Scale 0-10, 0=very bad/poor, 10=very good/excellent. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| Secondary | Stinging and Burning Sensation | Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination. Scale 0-10, 0=difficult to wear, 10=no sensation at all. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Aosept Clearcare / Comfilcon A Combination | Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study. Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system comfilcon A: contact lens | 0 | 33 | 0 | 33 |
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| After 8 hours of wear |
|
| Before removal |
|
| All day comfort |
|
| After 8 hours of wear |
|
| Before removal |
|
| All day dryness |
|