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The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOTAL1 | Experimental | Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality |
|
| 1-DAY | Active Comparator | Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses | Device | Water Gradient silicon hydrogel daily disposable contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Corrected Distance Visual Acuity (VA) | Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint. | Week 4 |
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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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Of the 39 enrolled, 2 subjects were discontinued (1 screen failure, 1 due to lens power not available) prior to randomization. This reporting group includes all randomized subjects (37).
Subjects were recruited from 4 investigational sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | TOTAL1 | Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality |
| FG001 | 1-DAY | Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all subjects/eyes exposed to any test or control product evaluated in the study (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | TOTAL1 | Delefilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality |
| BG001 | 1-DAY | Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality |
| 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 | Monocular Corrected Distance Visual Acuity (VA) | Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint. | Safety Analysis Set with non-missing response | Posted | Mean | Standard Deviation | logMAR | Week 4 | Eyes | Eyes |
|
Dispense through study completion, an average of 4 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 study lenses. 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. "At Risk" population for ocular AEs is included with unit of "eyes."
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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 | TOTAL1 Ocular - Right Eye | Right eyes exposed to delefilcon A contact lenses | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
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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 20, 2018 | May 29, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 13, 2018 | May 29, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Senofilcon A contact lenses | Device | Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology |
|
|
| Pittsburg |
| Kansas |
| 66762 |
| United States |
| Alcon Investigative Site | Powell | Ohio | 43065 | United States |
| Alcon Investigative Site | Warwick | Rhode Island | 02888 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
|
|
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | TOTAL1 Ocular - Left Eye | Left eyes exposed to delefilcon A contact lenses | 0 | 18 | 0 | 18 | 0 | 18 |
| EG002 | TOTAL1 Non-ocular | All subjects exposed to delefilcon A contact lenses | 0 | 18 | 0 | 18 | 0 | 18 |
| EG003 | 1-DAY Ocular - Right Eye | Right eyes exposed to senofilcon A contact lenses | 0 | 19 | 0 | 19 | 1 | 19 |
| EG004 | 1-DAY Ocular - Left Eye | Left eyes exposed to senofilcon A contact lenses | 0 | 19 | 0 | 19 | 1 | 19 |
| EG005 | 1-DAY Non-ocular | All subjects exposed to senofilcon A contact lenses | 0 | 19 | 0 | 19 | 1 | 19 |
| Conjunctival disorder | Eye disorders | MedDRA (21.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.