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The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.
The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DD T2/Oasys 1-Day | Other | Verofilcon A contact lenses and senofilcon A contact lenses worn in both eyes, each product, for 1 week on a daily wear basis, as randomized |
|
| DD T2/MyDay | Other | Verofilcon A contact lenses and stenfilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized |
|
| DD T2/Moist | Other | Verofilcon A contact lenses and etafilcon A contact lenses worn in both eyes, each product, for 1 week on a daily disposable basis, as randomized |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| verofilcon A contact lenses | Device | Investigational spherical silicone hydrogel contact lenses for daily disposable wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Quality of Vision | Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed. | Day 8, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Maitland | Florida | 32751 | United States | ||
| Alcon Investigative Site |
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Of the 68 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (66).
Subjects were recruited from 3 investigational sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | DD T2/Oasys 1-Day (Sequence 1) | Verofilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2. Each product worn bilaterally (in both eyes) for 1 week on a daily wear basis, as randomized |
| FG001 | Oasys 1-Day/DD T2 (Sequence 2) | Senofilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized |
| FG002 | DD T2/MyDay (Sequence 3) | Verofilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized |
| FG003 | MyDay/DD T2 (Sequence 4) | Stenfilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized |
| FG004 | DD T2/Moist (Sequence 5) | Verofilcon A contact lenses worn in Period 1, followed by etafilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized |
| FG005 | Moist/DD T2 (Sequence 6) | Etafilcon A contact lenses worn in Period 1, followed by verofilcon A contact lenses worn in Period 2. Each product worn bilaterally for 1 week on a daily wear basis, as randomized |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First Week of Wear |
| |||||||||||||
| Period 2, Second Week of Wear |
|
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 contact lenses with corresponding control product (senofilcon A, stenfilcon A, or etafilcon) worn during Period 1 and Period 2 in a crossover assignment, as randomized. |
| 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 | Overall Quality of Vision | Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked "Thinking back over the last week, please rate our study lenses. Rate eyes together." No formal hypotheses was conducted; hence no inferential testing was performed. | Safety Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Day 8, each product |
|
Dispense through study completion, an average of 2 weeks
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 (Sequence 1 and 2) | Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Project Lead, GCRA - Vision Care | Alcon, A Novartis Division | 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 | Nov 2, 2017 | Jan 18, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2017 | Jan 18, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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|
| senofilcon A contact lenses | Device | Commercially available spherical silicone hydrogel contact lenses for daily disposable wear |
|
|
| stenfilcon A contact lenses | Device | Commercially available spherical silicone hydrogel contact lenses for daily disposable wear |
|
|
| etafilcon A contact lenses | Device | Commercially available spherical silicone hydrogel contact lenses for daily disposable wear |
|
|
| Pensacola |
| Florida |
| 32503 |
| United States |
| Alcon Investigative Site | Johns Creek | Georgia | 30097 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG002 | DD T2 (Sequence 3 and 4) | Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week |
| OG003 | MyDay (Sequence 3 and 4) | Stenfilcon A contact lenses worn in Period 1 or Period 2 for 1 week |
| OG004 | DD T2 (Sequence 5 and 6) | Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week |
| OG005 | Moist (Sequence 5 and 6) | Etafilcon A contact lenses worn in Period 1 or Period 2 for 1 week |
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Oasys 1- Day (Sequence 1 and 2) | Senofilcon A contact lenses worn in Period 1 or Period 2 for 1 week | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | DD T2 (Sequence 3 and 4) | Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week | 0 | 22 | 0 | 22 | 0 | 22 |
| EG003 | MyDay (Sequence 3 and 4) | Stenfilcon A contact lenses worn in Period 1 or Period 2 for 1 week | 0 | 22 | 0 | 22 | 0 | 22 |
| EG004 | DD T2 (Sequence 5 and 6) | Verofilcon A contact lenses worn in Period 1 or Period 2 for 1 week | 0 | 22 | 0 | 22 | 0 | 22 |
| EG005 | Moist (Sequence 5 and 6) | Etafilcon A contact lenses worn in Period 1 or Period 2 for 1 week | 0 | 22 | 0 | 22 | 0 | 22 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.