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The purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in Multi-purpose solution FID 107027.
Corneal staining and subjective responses for ocular redness and comfort will be compared.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nelfilcon A soak / Nelfilcon A no-soak | Active Comparator | Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours. |
|
| Nelfilcon A no soak / nelfilcon A soak | Active Comparator | Nelfilcon A contact lenses inserted directly from the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours. |
|
| Etafilcon A soak / etafilcon A no soak | Active Comparator | Etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by etafilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours. |
|
| Etafilcon A no soak / etafilcon A soak | Active Comparator | Etafilcon A contact lenses inserted directly from the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A contact lens | Device | Commercially marketed, single vision, soft contact lens for daily disposable wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Corneal Staining Area | 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 fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together. | After 2 hours of wear |
| Total Corneal Staining Type | Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a 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 (>/= 1mm). The five regions were summed. | After 2 hours of wear |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Comfort | Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes feel..." with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable. | After 2 hours of wear |
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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 | 76134 | United States |
18 hours of no contact lens wear (glasses only) served as the wash out before Period 1. This reporting group includes all enrolled and dispensed participants as treated.
64 subjects currently wearing hydrogel or silicone hydrogel lenses on a daily wear schedule for at least two weeks were enrolled between 1/7/08 and 2/1/08 by 4 US optometry sites
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| ID | Title | Description |
|---|---|---|
| FG000 | Nelfilcon A Soak / Nelfilcon A no Soak | Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours. |
| FG001 | Nelfilcon A no Soak / Nelfilcon A Soak | Nelfilcon A contact lenses inserted directly out of the blister package, followed by nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours. |
| FG002 | Etafilcon A Soak / Etafilcon A no Soak | Nelfilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution, followed by nelfilcon A contact lenses inserted directly from the blister package. Each pair of lenses worn for 2 hours. |
| FG003 | Etafilcon A no Soak / Etafilcon Soak | Etafilcon A contact lenses inserted directly out of the blister package, followed by etafilcon A contact lenses inserted after being soaked overnight in a multi-purpose disinfecting solution. Each pair of lenses worn for 2 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention, 2 Hrs (+/- 30 Min) |
| |||||||||||||
| Washout Period, 3 Days (+/-1 Day) |
| |||||||||||||
| Second Intervention, 2 Hrs (+/- 30 Min) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nelfilcon A Contact Lens | Commercially marketed, single vision, soft contact lens for daily disposable wear |
| BG001 | Etafilcon A Contact Lens | Commercially marketed, single vision, soft contact lens for daily disposable wear |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | This reporting group is based on the number of subjects in the evaluable population. |
| 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 | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Ocular Comfort | Ocular comfort was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes feel..." with one of the following responses: 1-very comfortable; 2-comfortable; 3-neither comfortable nor uncomfortable; 4-uncomfortable; 5-very uncomfortable. | This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated. | Posted | Apr 2009 | Mean | Standard Deviation | Units on a scale | After 2 hours of wear |
|
For the duration of the study: 26 days.
The safety population is defined as subjects who fulfilled the study entry criteria and had at least one insertion of a daily disposable study lens.
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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 | Nelfilcon A / FID 107027 | Nelfilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| Etafilcon A contact lens | Device | Commercially marketed, single vision, soft contact lens for daily disposable wear |
|
|
| FID 107027 solution | Device | Commercially marketed solution for contact lens disinfection |
|
|
| Ocular Redness | Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes look..." with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red. | After two hours of wear |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age Continuous | This reporting group is based on the number of subjects in the evaluable population. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | This reporting group is based on the number of subjects in the evaluable population. | Count of Participants | Participants |
|
Nelfilcon A contact lenses inserted directly out of the blister package |
| OG002 | Etafilcon A / FID 107027 | Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion |
| OG003 | Etafilcon A / no Soak | Etafilcon A contact lenses inserted directly out of the blister package |
|
|
| Primary | Average Corneal Staining Area | 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 fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a yellow filter. Percentage corneal staining area was recorded in increments of ten, and the percentages of the five regions were averaged together. | This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated. | Posted | Mean | Standard Deviation | Percentage area of cornea | After 2 hours of wear |
|
|
|
| Secondary | Ocular Redness | Ocular redness was recorded by the participant on a questionnaire using a 5-point scale. Participant completed the sentence, "Right now my eyes look..." with one of the following responses: 1-very white; 2-white; 3-neither white nor red; 4-red; 5-very red. | This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated. | Posted | Mean | Standard Deviation | Units on a scale | After two hours of wear |
|
|
|
| Primary | Total Corneal Staining Type | Total corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The investigator instilled fluorescein dye and examined the cornea with a slit lamp, i.e., biomicroscope and a 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 (>/= 1mm). The five regions were summed. | This reporting group is based on the number of subjects in the evaluable population for the indicated lens as treated. | Posted | Mean | Standard Deviation | Units on a scale | After 2 hours of wear |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Nelfilcon A / no Soak | Nelfilcon A contact lenses inserted directly out of the blister package | 0 | 30 | 0 | 30 |
| EG002 | Etafilcon A / FID 107027 | Etafilcon A contact lenses soaked overnight in multi-purpose disinfection solution (MPDS) prior to insertion | 0 | 34 | 0 | 34 |
| EG003 | Etafilcon / no Soak | Etafilcon A contact lenses inserted directly out of the blister package | 0 | 34 | 0 | 34 |
The PI should hold confidential, and not disclose directly or indirectly to any third party other than Contractors, the data arising out of the study.