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The purpose of this study is to clinically evaluate solution-related corneal staining with an investigational multi-purpose disinfecting solution (MPDS) in hydrogel and silicone hydrogel contact lens wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID 114675A | Experimental | FID 114675A used for 7 days, per protocol-specified instructions. Silicone hydrogel or hydrogel contact lenses worn bilaterally on a daily wear basis, one brand only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID 114675A Multi-Purpose Disinfecting Solution (MPDS) | Device | Investigational solution intended for use as a cleaning, rinsing, conditioning, disinfecting, and storage solution for silicone hydrogel (SiH) contact lenses |
| Measure | Description | Time Frame |
|---|---|---|
| Solution-Related Corneal Staining | Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Lens Comfort | Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, "Over the previous 2-3 hours, my lenses felt comfortable," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree. | Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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110 participants with normal eyes (other than vision correction) were enrolled in the study. After the screening visit, particpants discontinued contact lens wear and wore their glasses for at least 2 days as a washout prior to the baseline/dispensing visit.
Participants were recruited from 6 US study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | FID 114675A | FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Etafilcon A contact lens (ACUVUE® 2™) | Device | Commercially marketed hydrogel contact lens for daily wear use |
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| Senofilcon A contact lens (ACUVUE® OASYS™) | Device | Commercially marketed silicone hydrogel contact lens for daily wear use |
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| Lotrafilcon B contact lens (O2 OPTIX®) | Device | Commercially marketed silicone hydrogel contact lens for daily wear use |
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| Balafilcon A contact lens (PureVision®) | Device | Commercially marketed silicone hydrogel contact lens for daily wear use |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | FID 114675A | FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Solution-Related Corneal Staining | Corneal staining was assessed by the investigator using fluorescein dye, a yellow filter, and a slit lamp. Corneal staining was graded on a continuous scale of 0% (no staining in the region) to 100% (staining covers entire region) in 1% increments for 5 corneal regions (central, nasal, temporal, inferior, and superior). Solution-related corneal staining was defined as ≥20% corneal staining area in at least 3 corneal regions of both eyes. | Intent to treat: All participants who received regimen and had at least one on-therapy visit. | Posted | Number | Percentage of participants | Day 7 |
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| Secondary | Mean Lens Comfort | Lens comfort was assessed by the participant on a 5-point Likert scale prior to any examination. The participant was instructed to select a single response to the statement, "Over the previous 2-3 hours, my lenses felt comfortable," with 1 = strongly disagree, 2 = disagree, 3 = undecided, 4 = agree, and 5 = strongly agree. | Intent to treat: All participant who received regimen and had at least one on-therapy study visit. | Posted | Mean | Standard Deviation | Units on a scale | Day 7 |
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Adverse events were collected for the duration of the study: 24 March 2009 to 19 June 2009.
This reporting group includes all participants enrolled and exposed to test regimen.
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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 | FID 114675A | Investigational multi-purpose contact lens solution | 0 | 110 | 0 | 110 |
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Alcon reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 1-888-451-3937 | medinfo@alconlabs.com |
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