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The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DACP/MyDay | Other | Nelfilcon A contact lenses worn in Period 1, with stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day. |
|
| MyDay/DACP | Other | Stenfilcon A contact lenses worn in Period 1, with nelfilcon A contact lenses in Period 2. Each product worn bilaterally for 12 hours over 1 day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A contact lenses | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear | The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated. | Day 1, Hour 12, each period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear | The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Medical Affairs, Clinical Manager, Vision Care | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Jena | Germany |
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Subjects were recruited from 1 investigational site located in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | DACP/MyDay | Nelfilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses in Period 2 |
| FG001 | MyDay/DACP | Stenfilcon A contact lenses worn in Period 1, followed by nelfilcon A contact lenses in Period 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 12 Hours |
| |||||||||||||
| Period 2, Second 12 Hours |
|
This analysis group includes all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Nelfilcon A and stenfilcon A contact lenses worn for 12 hours each in Period 1 and 2 as randomized |
| 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 | Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear | The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated. | This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan. | Posted | Mean | Standard Deviation | seconds | Day 1, Hour 12, each period |
|
Adverse events were collected for the duration of the study (March 2014 to April 2014). This analysis population includes all participants/eyes exposed to any investigational product evaluated in this study.
An adverse event was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign in subjects, users or other persons, whether or not related to the medical device.
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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 | DACP | Nelfilcon A contact lenses |
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There was a high censoring rate observed with the objective measurements and therefore there are limitations to the conclusions that may be drawn.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs Brand 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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| Stenfilcon A contact lenses | Device |
|
|
| Hour 12 |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| MyDay |
Stenfilcon A contact lenses |
|
|
| Secondary | Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear | The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated. | This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan. | Posted | Mean | Standard Deviation | percent distortion per second | Hour 12 |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | MyDay | Stenfilcon A contact lenses | 0 | 30 | 0 | 30 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.