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The purpose of this study was to evaluate visual acuity at distance when wearing DDT2 contact lenses compared to Clariti contact lenses.
Subjects were expected to attend 3 study visits and wear the DDT2 and Clariti study lenses in a crossover design for approximately 14 - 20 days (7 - 10 days for each product).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DDT2, then Clariti | Other | Verofilcon A contact lenses worn first, with somofilcon 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. |
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| Clariti, then DDT2 | Other | Somofilcon 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, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Jacksonville | Florida | 32256 | United States | ||
| Alcon Investigative Site |
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Of the 154 enrolled, 2 were exited from the study as screen failures and 1 subject was randomized but not exposed. This reporting group includes all exposed subjects (151).
This study was performed at 8 study centers in the United States (US).
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| ID | Title | Description |
|---|---|---|
| FG000 | DDT2, Then Clariti | Verofilcon A contact lenses worn first, with somofilcon 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. |
| FG001 | Clariti, Then DDT2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Wear Period (8 -1/+2 Days) |
|
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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 | Jun 25, 2020 |
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| Somofilcon A contact lenses | Device | Commercially available daily disposable soft contact lenses |
|
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| Maitland |
| Florida |
| 32751 |
| United States |
| Alcon Investigative Site | Orlando | Florida | 32803 | United States |
| Alcon Investigative Site | Bloomington | Illinois | 61701 | United States |
| Alcon Investigative Site | Powell | Ohio | 43065 | United States |
| Alcon Investigative Site | Warwick | Rhode Island | 02888 | United States |
| Alcon Investigative Site | Brentwood | Tennessee | 37027 | United States |
| Alcon Investigative Site | Memphis | Tennessee | 38111 | United States |
Somofilcon 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Second Wear (8 -1/+2 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | DDT2, Then Clariti | Verofilcon A contact lenses worn first, with somofilcon 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. Verofilcon A contact lenses: Investigational daily disposable soft contact lenses Somofilcon A contact lenses: Commercially available daily disposable soft contact lenses |
| BG001 | Clariti, Then DDT2 | Somofilcon 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. Verofilcon A contact lenses: Investigational daily disposable soft contact lenses Somofilcon A contact lenses: Commercially available daily disposable soft contact lenses |
| BG002 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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/eyes with non-missing responses, 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 |
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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. | 0 | 302 | 0 | 302 | 0 | 302 |
| 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 | 151 | 0 | 151 | 0 | 151 |
| EG002 | Clariti - Ocular | Somofilcon 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 | 298 | 0 | 298 | 0 | 298 |
| EG003 | Clariti - Systemic / Nonocular | Somofilcon 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 | 149 | 0 | 149 | 0 | 149 |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CDMA Project Lead, Vision Care | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 2, 2019 | Jun 25, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| American Indian or Alaska Native |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| Multi-racial |
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