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The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID122819, then stenfilcon A | Other | FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week |
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| Stenfilcon A, then FID122819 | Other | Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID122819 contact lenses | Device | Investigational spherical silicone hydrogel contact lenses for daily disposable wear |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity (VA) | VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis. | Baseline/Dispense (Day 1), Week 1, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Manager, Trial Management Operations | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Longwood | Florida | 32779 | United States | ||
| Alcon Investigative Site |
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Of the 54 enrolled, 3 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (51).
Subjects were recruited from 3 study centers located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | FID122819, Then Stenfilcon A | FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week. |
| FG001 | Stenfilcon A, Then FID122819 | Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week. |
| 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 randomized subjects exposed to any study lens evaluated in this study. Each subject/eye was analyzed according to the respective randomized lens, irrespective of the exposure (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | FID122819 and stenfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment. |
| 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 | Visual Acuity (VA) | VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis. | Full Analysis Set | Posted | Mean | Standard Deviation | logMAR | Baseline/Dispense (Day 1), Week 1, each product | Eyes | Eyes |
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Dispense through study completion, an average of 2 weeks
Adverse Events (AEs) were 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. This analysis population includes all subjects/eyes exposed to any study lens evaluated (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 | FID122819 | Subjects exposed to FID122819 contact lenses during Period 1 or Period 2 |
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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 | Mar 7, 2017 | Jan 7, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 21, 2017 | Jan 7, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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Alcon Observer and Sponsor personnel were also masked.
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| Stenfilcon A contact lenses | Device | Commercially available spherical silicone hydrogel contact lenses for daily disposable wear |
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| Maitland |
| Florida |
| 32751 |
| United States |
| Alcon Investigative Site | Johns Creek | Georgia | 30097 | United States |
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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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| 0 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Stenfilcon A | Subjects exposed to stenfilcon A contact lenses during Period 1 or Period 2 | 0 | 51 | 0 | 51 | 0 | 51 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
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