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The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID 114675A | Experimental | Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to one eye, with contact lens removed directly from the blister pack assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours. |
|
| Blister Pack | Active Comparator | Contact lens removed directly from the blister pack randomly assigned to one eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID 114675A multi-purpose disinfecting solution (MPDS) | Device | Investigational multi-purpose disinfecting solution intended for use as a cleaning, reconditioning, rinsing, disinfecting, and storage solution for silicone hydrogel and soft contact lenses. |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Wettability | As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated. | 16 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76314 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | FID 114675A | Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear. |
| FG001 | Blister Pack | Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FID 114675A | Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear. |
| BG001 | Blister Pack |
| 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 | Lens Wettability | As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated. | Intent to treat. All subject-eyes that received contact lenses pre-soaked per treatment regimen and completed Visit 2 (Day 1 - Exit at 16 hours) were included in the ITT data set. | Posted | Number | 95% Confidence Interval | percentage of lenses | 16 hours |
|
Adverse events were collected for the duration of the study: October 11, 2010 through February 2, 2011.
All subjects who received contact lenses pre-soaked per treatment regimen were evaluable for the safety analysis.
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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 | Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Alcon Clinical | Alcon Research, Ltd. | 1-888-451-3937 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003263 | Contact Lenses, Hydrophilic |
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Soft contact lens | Device | Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense. |
|
|
| Blister pack solution | Device | Commercially approved storage solution as found in the contact lens blister pack. |
|
|
Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Blister Pack | Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear. |
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Blister Pack | Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear. | 0 | 66 | 0 | 66 |
Alcon reserves the right of prior review of any publication or presentation of information related to the study.