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An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biotrue MPS | Active Comparator |
| |
| Investigational MPS | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotrue MPS | Device | Multi-purpose contact lens care solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining by Wear Time | All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens. | 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Solution Preference | All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference. | Day 4 |
| Overall Ocular Comfort | All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugenia Y Kao, OD | AMO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Medical Optics Inc | Santa Ana | California | 92705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biotrue/Investigational MPS | Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Biotrue/Investigational MPS | Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period. |
| 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, Customized | Number |
| 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 by Wear Time | All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens. | Corneal Staining Severity at Scheduled Visits (Safety Population) | Posted | Number | participants | 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4 |
|
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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 | Biotrue/Investigational MPS | Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager, Clinical Research | Abbott Medical Optics | 714.247.8723 | eugenia.kao@amo.abbott.com |
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| Investigational MPS |
| Device |
Multi-purpose contact lens care solution |
|
| Day 4 |
| participants |
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| Sex/Gender, Customized | Gender was not an analysis endpoint for this study. | Number | participants |
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| Investigational MPS |
Paired/parallel eye evaluation; each subject used both used the Investigational MPS and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period. |
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| Secondary | Subjective Solution Preference | All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference. | All subjects who completed the study were included in the analysis per protocol. | Posted | Count of Participants | Participants | Day 4 |
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| Secondary | Overall Ocular Comfort | All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt. | All subjects who completed the study were included in the analysis per protocol. | Posted | Mean | Standard Deviation | score on a scale | Day 4 |
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| 0 |
| 29 |
| 0 |
| 29 |
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| Subject reported solutions were about the same |
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