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The purpose of this study is to assess the clinical performance of DAILIES TOTAL1® spherical soft contact lenses over approximately 1 week of daily wear.
Subjects will be expected to attend 2 visits (Visit 1 Screen/Baseline/ Dispense; and Visit 2 Week 1 Follow-up/ Exit). The total duration of a subject's participation in the study as well as exposure to the contact lenses will be approximately 1 week (6-8 days of contact lens wear).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAILIES TOTAL1 | Experimental | Delefilcon A contact lenses worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses will be worn in a daily disposable manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses | Device | Daily disposable, silicone hydrogel spherical contact lenses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance VA With Study Lenses at Week 1 | Visual acuity (VA) was measured for each eye individually with study lenses on eye using letter charts. VA was recorded in Snellen where 20/20 represents normal distance eyesight and 20/15 represents better than normal eyesight. No hypothesis testing was prespecified for this endpoint. | Week 1 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, CRD Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallahassee Eye Center | Tallahassee | Florida | 32308 | United States | ||
| The Eye Doctors, Inc. |
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Of the 97 enrolled, 1 subject was exited as a screen failure prior to being exposed to the product. This reporting group includes all participants who were exposed to the product (96).
Participants were recruited from 6 investigative sites located in 1 country (US).
| ID | Title | Description |
|---|---|---|
| FG000 | DAILIES TOTAL1 | Delefilcon A contact lenses (daily disposable, silicone hydrogel spherical contact lenses) worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses were worn in a daily disposable manner. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The safety analysis set included all subjects/eyes exposed to DAILIES TOTAL1 lenses evaluated in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | DAILIES TOTAL1 | Delefilcon A contact lenses (daily disposable, silicone hydrogel spherical contact lenses) worn in both eyes for the typical number of hours the subject wears his/her habitual contact lenses. The lenses were worn in a daily disposable manner. |
| 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 VA With Study Lenses at Week 1 | Visual acuity (VA) was measured for each eye individually with study lenses on eye using letter charts. VA was recorded in Snellen where 20/20 represents normal distance eyesight and 20/15 represents better than normal eyesight. No hypothesis testing was prespecified for this endpoint. | The safety analysis set included all subjects/eyes exposed to DAILIES TOTAL1 lenses evaluated in this study. | Posted | Number | eyes | Week 1 | eyes | eyes |
|
Adverse Events (AEs) were collected from time of consent to study exit, up to approximately 6 to 8 days of contact lens wear.
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. This analysis population includes all subjects/eyes exposed to DAILIES TOTAL1 lenses evaluated in this study. The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group.
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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 | Pretreatment | Events reported in this group occurred prior to exposure to delefilcon A contact lenses. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Project Lead, Vision Care | Alcon Research, LLC | 8884513937 | 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 | Aug 28, 2023 | Oct 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2023 | Oct 24, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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In this single arm study, the subject will be masked to the lens type.
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| Eden Prairie |
| Minnesota |
| 55344 |
| United States |
| Oculus Research, Inc. | Garner | North Carolina | 27529 | United States |
| ProCare Vision Center | Granville | Ohio | 43023 | United States |
| Wyomissing Optometric Center | Wyomissing | Pennsylvania | 19610 | United States |
| Optometry Group, PLLC | Memphis | Tennessee | 38111 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
|
| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | DAILIES TOTAL1 Ocular | Events reported in this group occurred while exposed to delefilcon A contact lenses. | 0 | 192 | 0 | 192 | 0 | 192 |
| EG002 | DAILIES TOTAL1 Nonocular | Events reported in this group occurred while exposed to delefilcon A contact lenses. | 0 | 96 | 0 | 96 | 0 | 96 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study