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The purpose of this study was to compare the clinical performance of the new DAILIES® AquaComfort PLUS® FreshTech (DACP FreshTech) contact lenses to an already marketed daily disposable contact lens, DAILIES® AquaComfort PLUS® (DACP).
Subjects attended 4 scheduled visits for an expected duration of participation of 3 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DACP FreshTech, then DACP | Other | DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day. |
|
| DACP, then DACP FreshTech | Other | DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DACP FreshTech contact lenses | Device | Nelfilcon A soft contact lenses with a modified lens design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Distance Visual Acuity (VA) With Study Lenses | VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. | Week 1, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Clinical Project Lead | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Bloomington | Indiana | 47405 | United States |
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Of the 79 enrolled subjects, 11 were screen failures and 1 withdrew prior to randomization. This reporting group includes all randomized subjects (67).
The study was conducted at a single investigative site in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | DACP FreshTech, Then DACP | DACP FreshTech contact lenses worn first, followed by DACP contact lenses, as randomized. Each product was worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day. |
| FG001 | DACP, Then DACP FreshTech | DACP contact lenses worn first, followed by DACP FreshTech contact lenses, as randomized.. Each product was worn in both eyes for approximately 8 hours per day, for 1 week with a new pair of lenses worn each day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Wear Period (1 Week) |
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| Second Wear Period (1 Week) |
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This analysis population includes all randomized subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | DACP FreshTech contact lenses and DACP 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 | Mean Distance Visual Acuity (VA) With Study Lenses | VA was assessed at a distance of 4 meters using a letter chart and was measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. | Full Analysis Set: All randomized subjects (as randomized) who were exposed to any study lenses, not including the optimized habitual and trial fit lenses. | Posted | Mean | Standard Deviation | logMAR | Week 1, each product |
|
Adverse events were collected from time of consent to study exit, approximately 3 weeks. The safety analysis set included all all randomized subjects (as treated) who were exposed to any study lenses, not including the optimized habitual and trial-fit lenses.
Adverse events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for 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 | DACP FreshTech - Ocular | Nelfilcon A soft contact lenses with a modified lens design worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 7 days with a new pair of lenses worn each day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CDMA Project Lead, Vision Care | Alcon Research, LLC | 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 | Oct 7, 2019 | Oct 16, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 15, 2019 | Oct 19, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001248 | Asthenopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| DACP contact lenses | Device | Nelfilcon A 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 | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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DACP contact lenses worn in both eyes for approximately 8 hours per day for 1 week with a new pair of lenses worn each day |
|
|
|
| 0 |
| 134 |
| 0 |
| 134 |
| 0 |
| 134 |
| EG001 | DACP FreshTech - Systemic / Nonocular | Nelfilcon A soft contact lenses with a modified lens design worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 7 days with a new pair of lenses worn each day. | 0 | 67 | 0 | 67 | 0 | 67 |
| EG002 | DACP - Ocular | Nelfilcon A soft contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 7 days with a new pair of lenses worn each day. | 0 | 132 | 0 | 132 | 0 | 132 |
| EG003 | DACP - Systemic / Nonocular | Nelfilcon A soft contact lenses worn bilaterally (in both eyes) during Period 1 or Period 2, as randomized, for approximately 7 days with a new pair of lenses worn each day. | 0 | 66 | 0 | 66 | 0 | 66 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.