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The purpose of this study was to describe mean differences in corneal staining (type and area) for OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS) at Day 30 compared to Baseline (Day 0).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPTI-FREE | Experimental | OPTI-FREE PureMoist multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPTI-FREE PureMoist | Device | Commercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30 | Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together. | Baseline (Day 0), Day 30 |
| Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30 | Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (>/= 1 mm). The five regions were summed, for a summed total range of 0-20. | Baseline (Day 0), Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jami R Kern | 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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Participants were recruited from 3 study centers in the Netherlands, 3 study centers in Sweden, and 1 study center in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | OPTI-FREE | Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | OPTI-FREE | Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen. |
| 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 | Mean Change From Baseline (Day 0) in Average Corneal Staining Area at Day 30 | Percentage corneal staining was assessed by the investigator for each of five regions of the cornea; i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Percentage corneal staining was recorded in increments of ten, and the percentages of the five regions were averaged together. | Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses. | Posted | Mean | Standard Deviation | Percentage of corneal staining | Baseline (Day 0), Day 30 |
|
Adverse events were collected for the duration of the study: 3 months, 2 weeks, 2 days.
All subjects enrolled in the study and exposed to test regimen were evaluable for safety analyses.
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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 | OPTI-FREE | Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jami Kern, Ph.D., Global Medical Affairs | Alcon Research, Ltd. | 800-862-5266 |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | Mean Change From Baseline (Day 0) in Total Corneal Staining Type at Day 30 | Corneal staining type was assessed by the investigator for each of five regions of the cornea, i.e., four quadrants plus central. The investigator instilled flourescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and yellow filter. Corneal staining type was recorded on a 5-point scale for each region: 0=none; 1=micropunctate; 2=macropunctate; 3=coalesced macropunctate; 4=patch (>/= 1 mm). The five regions were summed, for a summed total range of 0-20. | Intent to treat. All subjects who were enrolled in the study and completed at least one on-regimen study visit were evaluable for intent-to-treat analyses. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (Day 0), Day 30 |
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| 0 |
| 175 |
| 0 |
| 175 |
Alcon reserves the right of prior review of any publication or presentation of information related to the study.