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The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DACP Digital then DACP | Other | Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality. |
|
| DACP then DACP Digital | Other | Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A digital contact lenses | Device | Silicone hydrogel digital contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity (VA) (logMAR, OU) | VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity. | Day 7, each product |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Vision | Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis. | Day 7, 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 | Bloomington | Illinois | 61701 | United States | ||
| Alcon Investigative Site |
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All 60 enrolled subjects were randomized and exposed to the investigational products.
Subjects were recruited from 5 investigative sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | DACP Digital Then DACP | Nelfilcon A digital contact lenses worn first, followed by nelfilcon A contact lenses. Each product worn bilaterally (in both eyes) for 7 days in a daily disposable modality. |
| FG001 | DACP Then DACP Digital | Nelfilcon A contact lenses worn first, followed by nelfilcon A digital contact lenses. Each product worn bilaterally for 7 days in a daily disposable modality. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 7 Days of Wear |
| |||||||||||||
| Period 2, Second 7 Days of Wear |
|
This analysis population includes all randomized subjects who were exposed to any study lenses evaluated in this study (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Nelfilcon A digital contact lenses and nelfilcon A contact lenses 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 | Distance Visual Acuity (VA) (logMAR, OU) | VA was tested under photopic (well-lit) conditions using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart positioned 6 meters from the subject. VA was collected bilaterally (OU) and measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on the ETDRS chart. A lower numeric value represents better visual acuity. | Full Analysis Set with non-missing response | Posted | Mean | Standard Deviation | logMAR | Day 7, each product |
|
Dispense through study completion, an average of 14 days
Adverse Events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects/eyes that were exposed to any study lenses in the study (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 | DACP Digital | All subjects exposed to nelfilcon A digital contact lenses | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CDMA Project Lead | 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 | Jul 16, 2018 | May 22, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2018 | May 22, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Nelfilcon A contact lenses | Device | Silicone hydrogel spherical contact lenses |
|
|
| Powell |
| Ohio |
| 43065 |
| United States |
| Alcon Investigative Site | Brentwood | Tennessee | 37027 | United States |
| Alcon Investigative Site | Memphis | Tennessee | 38104 | United States |
| Alcon Investigative Site | Memphis | Tennessee | 38111 | United States |
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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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Nelfilcon A contact lenses worn bilaterally for 7 days in a daily disposable modality.
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|
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| Secondary | Overall Vision | Subjective rating of overall vision on a scale of 1 (Poor) to 10 (Excellent). Both eyes contributed to the analysis. | Full Analysis Set with non-missing response | Posted | Mean | Standard Deviation | units on a scale | Day 7, each product |
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|
|
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | DACP | All subjects exposed to nelfilcon A contact lenses | 0 | 60 | 0 | 60 | 0 | 60 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.