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The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOFINITY ENERGYS then BIOFINITY | Other | Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality. |
|
| BIOFINITY then BIOFINITY ENERGYS | Other | Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comfilcon A with Digital Zone Optics™ contact lenses | Device | Silicone hydrogel spherical contact lenses with Digital Zone Optics™ |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective Rating of Overall Vision | Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint. | Day 7, each product |
| Measure | Description | Time Frame |
|---|---|---|
| Over-refraction | Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint. | Day 1 (Dispense), each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alcon, A Novartis Division | Alcon, A Novartis Division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Maitland | Florida | 32751 | United States |
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All 15 enrolled subjects were randomized and exposed to investigational product. This reporting group includes all randomized and treated subjects (15).
Subjects were recruited from one study site located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | BIOFINITY ENERGYS Then BIOFINITY | Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality. |
| FG001 | BIOFINITY Then BIOFINITY ENERGYS | Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 7 Days of Wear |
| |||||||||||||
| Period 2, Second 7 Days 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 | Comfilcon A with Digital Zone Optics™ contact lenses and comfilcon 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 | Subjective Rating of Overall Vision | Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint. | Safety Analysis Set | Posted | Mean | Standard Deviation | units on a scale | Day 7, each product |
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Dispense through study completion, an average of 14 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. Safety Analysis Set, based on treatment-specific exposure. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
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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 | BIOFINITY ENERGYS | All subjects exposed to comfilcon A with Digital Zone Optics™ contact lenses |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr 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 1, 2018 | Feb 13, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2018 | Feb 13, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Comfilcon A contact lenses | Device | Silicone hydrogel spherical 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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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Over-refraction | Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint. | Safety Analysis Set | Posted | Count of Units | Eyes | Day 1 (Dispense), each product | Eyes | Eyes |
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|
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | BIOFINITY | All subject exposed to comfilcon A contact lenses | 0 | 15 | 0 | 15 | 0 | 15 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| +0.25D |
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