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The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DT1, then AO1D | Other | Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality. |
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| AO1D, then DT1 | Other | Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14 | Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage. | Day 14, each product |
| Measure | Description | Time Frame |
|---|---|---|
| Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14 | The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Manager, Global Medical Affairs, GCRA | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
Of the 252 enrolled, 5 subjects were exited prior to randomization and 1 randomized subject was exited prior to treatment. This reporting group includes all randomized subjects who were exposed to a study product (test or control) (246).
Subjects were recruited from 12 study centers located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | DT1, Then AO1D | Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality. |
| FG001 | AO1D, Then DT1 | Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 14 Days of Wear |
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| Period 2, Second 14 Days of Wear |
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This analysis population includes all randomized subjects who were exposed to any study lens, except for lenses used at Visit 1 for parameter optimization and fitting (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Delefilcon A and senofilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment. |
| 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 | Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14 | Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage. | Full Analysis Set. Number Analyzed is the number of eyes with non-missing response. | Posted | Number | percentage of lenses | Day 14, each product | Eyes | Eyes |
|
Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pre-treatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) 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 | Pretreatment | All subjects who consented to participate in the study prior to initiation of study treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Franchise Head, Vision Care | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Senofilcon A contact lenses |
| Device |
|
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| Day 14, each product |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
Senofilcon A contact lenses worn bilaterally for 14 days in a daily wear, daily disposable modality |
|
|
| Secondary | Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14 | The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity. | Full Analysis Set. Number Analyzed is the number of eyes with non-missing responses, including only subjects from one site. | Posted | Mean | Standard Deviation | unitless | Day 14, each product | Eyes | Eyes |
|
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| 0 |
| 252 |
| 0 |
| 252 |
| 0 |
| 252 |
| EG001 | DAILIES TOTAL1 (DT1) | All subjects exposed to DT1 contact lenses, except for lenses used for parameter optimization and fitting | 0 | 246 | 0 | 246 | 0 | 246 |
| EG002 | ACUVUE OASYS 1-DAY (AO1D) | All subjects exposed to AO1D contact lenses, except for lenses used for parameter optimization and fitting | 0 | 246 | 0 | 246 | 0 | 246 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.