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| Name | Class |
|---|---|
| Aston University | OTHER |
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The purpose of this study was to compare the pre-lens tear film stability of DAILIES TOTAL1® silicone hydrogel daily disposable contact lenses with that of two other silicone hydrogel daily disposable contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dailies Total 1 | Experimental | Delefilcon A, followed by narafilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner. |
|
| TruEye | Active Comparator | Narafilcon A, followed by delefilcon A and filcon II 3 in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner. |
|
| Clariti | Active Comparator | Filcon II 3, followed by narafilcon A and delefilcon A in randomized order. Each product worn for 1 week in a daily wear, daily disposable manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lens | Device | Silicone hydrogel contact lens for single use, daily disposable wear. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time. | Day 7, 16 hours after lens insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jami Kern, PhD | Alcon Research | Study Director |
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This reporting group includes all enrolled participants.
Participants were recruited from one study center in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall | All enrolled participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | DT1, TruEye, and Clariti contact lenses worn in randomized, cross-over fashion for one week each |
| 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 | Pre-Lens Non-Invasive Tear Break-Up Time (PL-NITBUT) | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the corneal surface using a CA-1000 topographer, and the tear film reflection was observed on a 30-inch flat panel monitor. PL-NITBUT was recorded at the first sign of image distortion. Three measurements were taken and averaged together. A higher number represents a longer tear film break up time. | Posted | Mean | Standard Deviation | seconds | Day 7, 16 hours after lens insertion |
|
Adverse events were collected for the duration of the trial.
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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 | Dailies Total 1 | Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jami Kern, PhD | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| Narafilcon A contact lens | Device | Silicone hydrogel contact lens for single use, daily disposable wear. |
|
|
| Filcon II 3 contact lens | Device | Silicone hydrogel contact lens for single use, daily disposable wear |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| TruEye |
Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner. |
| OG002 | Clariti | Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner. |
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | TruEye | Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner. | 0 | 39 | 0 | 39 |
| EG002 | Clariti | Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner. | 0 | 39 | 0 | 39 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.