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The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment.
After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyDay, then 1DAVTE | Other | Stenfilcon A contact lenses, followed by narafilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality. |
|
| 1DAVTE, then MyDay | Other | Narafilcon A contact lenses, followed by stenfilcon A contact lenses. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stenfilcon A contact lenses | Device | Contact lenses worn during Period 1 or 2, as randomized |
|
| Measure | Description | Time Frame |
|---|---|---|
| High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10 | High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis. | Day 10, each product |
| Measure | Description | Time Frame |
|---|---|---|
| High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10 | High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis. | Day 10, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Manager, EMEA | Alcon, A Novartis Division | Study Director |
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Of the 66 enrolled participants, 2 participants were discontinued prior to randomization. This reporting group includes all randomized participants (64).
Participants were enrolled from 1 investigative site located in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Habitual, MyDay, 1DAVTE | Habitual contact lenses worn first, followed by stenfilcon A contact lenses in Period 1 and narafilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality. |
| FG001 | Habitual, 1DAVTE, MyDay | Habitual contact lenses worn first, followed by narafilcon A contact lenses in Period 1 and stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Habitual, 10 Days of Wear |
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| ||||||||||||||||||
| Period 1, 10 Days of Wear |
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| Period 2, 10 Days of Wear |
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This reporting group includes all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Habitual contact lenses worn first, followed by stenfilcon A contact lenses and narafilcon A contact lenses in Periods 1 and 2 as randomized. Each product worn bilaterally for 10 days in a daily wear, 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 | High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10 | High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis. | Intent to Treat | Posted | Mean | Standard Deviation | VA unit | Day 10, each product |
|
Adverse events (AEs) were collected from time of informed consent throughout the duration of a subject's participation in the study (up to 30 days). This analysis population includes all randomized participants exposed to investigational product (habitual, MyDay, and 1DAVTE) from time of product dispense (safety analysis set), based on treatment-specific exposure. One subject in the MyDay/1DAVTE arm wore habitual lenses during Period 1 and was not exposed to MyDay (discontinued at Period 1).
An 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 medical device. Ocular AEs are presented on the subject level, but reported by eye.
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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 | All subjects who consented to participate in the study prior to the initiation of study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney infection | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GMA Franchise Head - Vision Care, GCRA | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| Narafilcon A contact lenses | Device | Contact lenses worn during Period 1 or 2, as randomized |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 |
| 1DAVTE |
Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality |
|
|
| Secondary | High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10 | High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis. | Intent to Treat Subjects | Posted | Mean | Standard Deviation | VA unit | Day 10, each product |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Dailies Total 1 | Delefilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1 | 0 | 32 | 5 | 32 |
| EG002 | Clariti 1-Day | Somofilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1 | 0 | 32 | 0 | 32 |
| EG003 | MyDay | Stenfilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized | 1 | 60 | 0 | 60 |
| EG004 | 1DAVTE | Narafilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized | 1 | 61 | 0 | 61 |
| Renal vein thrombosis | Renal and urinary disorders |
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| Hordeolum | Infections and infestations | Incidences of hordeolum occurred in 2 out of 64 eyes (3.1%), here reported as 2/32 (6.25%) in order to keep all AE reports on the subject level. |
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| Foreign body in eye | Injury, poisoning and procedural complications | Incidences of foreign body in eye occurred in 2 out of 64 eyes (3.1%), here reported as 2/32 (6.25%) in order to keep all AE reports on the subject level. |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.