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The purpose of this study is to compare visual acuity between two daily disposable contact lenses.
The expected duration of subject participation in the study is approximately 2 weeks, with 3 scheduled visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MDACL, then DACL | Other | Modified delefilcon A contact lenses (MDACL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality. |
|
| DACL, then MDACL | Other | DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified delefilcon A contact lenses | Device | Spherical soft daily disposable contact lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| High Contrast Distance Visual Acuity (logMAR) | Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA. | Day 1 Dispense, Day 7 Follow-Up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. CDMA Project Lead, Vision Care | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Maitland | Florida | 32751 | United States | ||
| Alcon Investigative Site |
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Of the 62 subjects enrolled, 2 were exited as screen failures prior to randomization. This reporting group includes all randomized and exposed subjects (60).
This study was conducted at 5 investigative sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | MDACL, Then DACL | Modified delefilcon A contact lenses (MADCL) worn first, followed by delefilcon A contact lenses (DACL), as randomized. Each product worn bilaterally (in both eyes) for approximately 1 week in a daily disposable modality. |
| FG001 | DACL, Then MDACL | DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First Week of Wear |
|
| ||||||||||||||||||
| Period 2, Second Week of Wear |
|
All subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | MDACL, Then DACL | MDACL worn first, followed by DACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality. |
| BG001 | DACL, Then MDACL |
| 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 | High Contrast Distance Visual Acuity (logMAR) | Distance visual acuity (VA) testing was performed using letter charts. Each row of the chart contained 5 letters, with the letters on each row progressively smaller than the row above. The subject read the letters from larger to smaller. The test terminated when the subject either misidentified a majority of letters on 1 row or progressed to the smallest row of letters. Visual acuity scoring sheets were used to record the number of letters correctly read. LogMAR VA was calculated based on the total number of letters read incorrectly as follows: LogMAR Acuity = base reading + (0.02 x number of letters missed). A lower logMAR value indicates better VA. | All randomized subjects who were exposed to any study lenses evaluated in the study (Full Analysis Set), with non missing data. | Posted | Mean | Standard Deviation | logMar | Day 1 Dispense, Day 7 Follow-Up | eyes | eyes |
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Adverse events were collected (observed or reported) for the duration of the individual's participation in the study, approximately 2 weeks.
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study lenses. This analysis population includes all subjects/eyes exposed to any study lens evaluated in this study (Safety Analysis Set).
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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 | MDACL | MDACL worn for approximately 1 week, Period 1 or Period 2, as randomized |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. CDMA Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 30, 2018 | Dec 17, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 7, 2018 | Dec 17, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Delefilcon A contact lenses | Device | Spherical soft daily disposable contact lens |
|
|
| Orlando |
| Florida |
| 32803 |
| United States |
| Alcon Investigative Site | West Palm Beach | Florida | 33405 | United States |
| Alcon Investigative Site | Ann Arbor | Michigan | 48105 | United States |
| Alcon Investigative Site | Memphis | Tennessee | 38111 | United States |
| NOT COMPLETED |
|
DACL worn first, followed by MDACL, as randomized. Each product worn bilaterally for approximately 1 week in a daily disposable modality.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
MDACL worn for approximately 1 week, Period 1 or Period 2, as randomized
| OG001 | DACL | DACL worn for approximately 1 week, Period 1 or Period 2, as randomized |
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | DACL | DACL worn for approximately 1 week, Period 1 or Period 2, as randomized | 0 | 60 | 0 | 60 | 0 | 60 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
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