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The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Acuvue Moist contact lenses.
Subjects were expected to attend 3 study visits and wear study lenses for approximately 14 - 20 days (7 - 10 days for each product).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DDT2, then 1DAVM | Other | Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. |
|
| 1DAVM, then DDT2 | Other | Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product was worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verofilcon A contact lenses | Device | Investigational daily disposable soft contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Distance Visual Acuity With Study Lenses | Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. | Day 8, each product |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| CDMA Project Lead, Vision Care | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Jacksonville | Florida | 32256 | United States | ||
| Alcon Investigative Site |
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This reporting group includes all randomized subjects (92).
This study was performed at 5 study centers in the United States (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | DDT2, Then 1DAVM | Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. |
| FG001 | 1DAVM, Then DDT2 | Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Wear Period (8 -1/+2 Days) |
| |||||||||||||
| Second Wear Period (8 -1/+2 Days) |
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | DDT2, Then 1DAVM | Verofilcon A contact lenses worn first, with etafilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days in a daily disposable modality. |
| BG001 | 1DAVM, Then DDT2 |
| 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 | Least Squares Mean Distance Visual Acuity With Study Lenses | Visual acuity was assessed and collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. | Full Analysis Set (FAS): All randomized subjects who were exposed to any study lenses evaluated in this study, with the exception of the lenses used at Visit 1 for optimization and fitting. | Posted | Least Squares Mean | Standard Error | logMar | Day 8, each product | eyes | eyes |
|
Adverse events were collected from time of consent to study exit (approximately 14-20 days). The safety analysis set included all subjects/eyes exposed to any study lenses evaluated in this study, with the exception of the lenses used at Visit 1 for the purpose of parameter optimization and fitting, as they were not intended for the assessment of safety.
Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population of ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
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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 | DDT2 - Ocular | Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 8, 2019 | Apr 24, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2019 | Apr 24, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Etafilcon A contact lenses | Device | Commercially available daily disposable soft contact lenses |
|
|
| Maitland |
| Florida |
| 32751 |
| United States |
| Alcon Investigative Site | Orlando | Florida | 32803 | United States |
| Alcon Investigative Site | Powell | Ohio | 43065 | United States |
| Alcon Investigative Site | Memphis | Tennessee | 38111 | United States |
| NOT COMPLETED |
|
Etafilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each product worn bilaterally (in both eyes) for 8 -1/+2 days 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 |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| 1DAVM |
Etafilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. |
|
|
|
| 0 |
| 184 |
| 0 |
| 184 |
| 0 |
| 184 |
| EG001 | DDT2 - Systemic / Nonocular | Verofilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. | 0 | 92 | 0 | 92 | 0 | 92 |
| EG002 | 1DAVM - Ocular | Etafilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. | 0 | 184 | 0 | 184 | 0 | 184 |
| EG003 | 1DAVM - Systemic / Nonocular | Etafilcon A contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for 8 -1/+2 days in a daily disposable modality. | 0 | 92 | 0 | 92 | 0 | 92 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.