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The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.
In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated under a separate non-clinical protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 16hrs/15mins | Other | Delefilcon A contact lenses worn bilaterally (in both eyes) for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2. |
|
| 15mins/16hrs | Other | Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, followed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses | Device | Silicone hydrogel contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn | Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only. | Day 1 (for each period), 16 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Average Coefficient of Friction at 15 Minutes | Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only. | Day 1 (for each period), 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa L. Zoota, MPH, CCRA | Alcon Research | Study Director |
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This reporting group includes all randomized participants (15).
Participants were recruited from 1 study center located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | 16hr/15min | Delefilcon A contact lenses worn bilaterally for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2. |
| FG001 | 15min/16hr | Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, follwed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First Wear |
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| Period 2, Second Wear |
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This analysis population includes all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Delefilcon A contact lenses worn during Period 1 and Period 2 |
| Units | Counts |
|---|---|
| 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 |
| 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 | Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn | Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only. | This analysis population includes all participants who completed the study. | Posted | Mean | Standard Deviation | unitless | Day 1 (for each period), 16 hours |
|
Adverse events (AEs) were collected for the duration of the study (March 2014 - April 2014). This analysis population includes all participants exposed to the investigational product, based on treatment-specific exposure.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. AEs were obtained as solicited comments from the study participants and as observations by the Investigator.
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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 TOTAL1 | Delefilcon A contact lenses worn during Period 1 and Period 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal infiltrates | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cecile Maissa, Global Brand Medical Affairs Lead - Vision Care | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Average Coefficient of Friction at 15 Minutes | Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only. | This analysis population includes all participants who completed the study. | Posted | Mean | Standard Deviation | unitless | Day 1 (for each period), 15 minutes |
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| 0 |
| 15 |
| 2 |
| 15 |
| Ocular discomfort | Eye disorders | MedDRA 16.0 | Systematic Assessment |
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