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The purpose of this study is to evaluate the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® with UV Absorber (DT1 UV) contact lenses compared with current DAILIES TOTAL1® (DT1) contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DT1 UV | Experimental | Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours |
|
| DT1 | Active Comparator | Delefilcon A contact lenses worn bilaterally for 9 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses with UV Absorber | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes. | Day 1 at Hour 9 ± 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, GCRA | Alcon Research | Study Director |
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Of the 81 enrolled, 1 subject exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (80).
Subjects were recruited from 5 investigational sites located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | DT1 UV | Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours |
| FG001 | Dailies Total1 (DT1) | Delefilcon A contact lenses worn bilaterally for 9 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all randomized subjects who were exposed to the investigational product and satisfied specific evaluability criteria (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | DT1 UV | Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours |
| BG001 | Dailies Total1 (DT1) | Delefilcon A contact lenses worn bilaterally for 9 hours |
| 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 | Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes. | Full Analysis Set | Posted | Count of Units | Eyes | Day 1 at Hour 9 ± 3 hours | Eyes | Eyes |
|
Duration of enrollment = 1 Day
AEs 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 exposed to any investigational product evaluated in the study.
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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 | DT1 UV | Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead, Vision Care | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Delefilcon A contact lenses |
| Device |
|
|
| BG002 | Total | Total of all reporting groups |
| 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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|
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| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Dailies Total1 (DT1) | Delefilcon A contact lenses worn bilaterally for 9 hours | 0 | 39 | 0 | 39 | 0 | 39 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.