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The purpose of this study is to evaluate the overall performance of investigational contact lenses (DD T2) when compared to clariti® 1 day contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DD T2, then Clariti 1 Day | Other | Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable modality. |
|
| Clariti 1 Day, then DD T2 | Other | Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product worn bilaterally for 1 week in a daily disposable modality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| verofilcon A contact lenses | Device | Investigational daily disposable soft contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Quality of Vision | Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated. | Day 8, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alcon Research | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Maitland | Florida | 32751 | United States |
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A total of 22 subjects signed informed consent to participate in the study. This reporting group includes all randomized and exposed subjects (22).
Subjects were recruited from 1 investigative site located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | DDT2, Then Clariti 1 Day | Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second. Each product will be worn bilaterally (in both eyes) for 1 week in a daily disposable modality. |
| FG001 | Clariti 1 Day, Then DDT2 | Somofilcon A contact lenses worn first, with verofilcon A contact lenses worn second. Each product will be worn bilaterally for 1 week in a daily disposable modality. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First Week of Wear |
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| Period 2, Second Week of Wear |
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This analysis population includes all subjects/eyes exposed to any study lenses evaluated in this study (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Verofilcon A and somofilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. |
| 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 | Overall Quality of Vision | Overall quality of vision was measured as a subjective rating, collected binocularly on a scale of 1 (Poor) to 10 (Excellent). No inferences were made; therefore, no hypotheses were formulated. | Safety Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Day 8, each product |
|
Dispense through study completion, approximately 20 days
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Safety Analysis Set, based on treatment-specific exposure.
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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 | DD T2 | All subjects exposed to verofilcon A contact lenses | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Project Lead, GCRA - Vision Care | Alcon Research | 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 | Apr 20, 2018 | Jan 18, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2018 | Jan 18, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| somofilcon A contact lenses | Device | Commercially available daily disposable soft contact lenses |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Clariti 1 Day | All subjects exposed to somofilcon A contact lenses | 0 | 22 | 0 | 22 | 0 | 22 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.