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The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.
This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Other | Delefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period. |
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| Sequence 2 | Other | Narafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period. |
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| Sequence 3 | Other | Somofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period. |
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| Sequence 4 | Other | No lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delefilcon A contact lenses | Device | Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions |
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| Measure | Description | Time Frame |
|---|---|---|
| Tear Film Evaporation Rate | Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance. | Day 1, Hour 8, each product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, Clinical Trial Management | Alcon Research | Study Director |
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Of the 37 enrolled, 7 subjects were exited as screen failures prior to randomization and 1 subject discontinued after randomization prior to exposure to the investigational product. This reporting group includes all randomized and exposed subjects (29).
Subjects were recruited from 1 study center located in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | DAILIES TOTAL1 (DT1)/TruEye/clariti/No Lens |
| FG001 | Sequence 2 | TruEye/No Lens/DT1/clariti |
| FG002 | Sequence 3 | clariti/DT1/No Lens/TruEye |
| FG003 | Sequence 4 | No Lens/clariti/TruEye/DT1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Exposure (8 Hours) |
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| Second Exposure (8 Hours) |
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| Third Exposure (8 Hours) |
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| Fourth Exposure (8 Hours) |
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This analysis population includes all subjects/eyes exposed to any investigational product (including the 'No Lens wear' treatment) evaluated in this study, except for lenses used at Visit 1 for the purpose of parameter optimization and fitting, as they were not intended for the assessment of safety and effectiveness (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Delefilcon A, narafilcon A, and somofilcon A contact lenses worn bilaterally (in both eyes) and a period of no lens wear in a randomized crossover fashion |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Tear Film Evaporation Rate | Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance. | This analysis population includes all randomized subjects (Intent-to-Treat). To address the primary objective of comparing Lens vs. No Lens, results from all 3 study lenses are combined. Therefore, subjects (eyes) are counted multiple times in Lens group due to crossover design and number of eyes with non-missing response is reported. | Posted | Mean | Standard Deviation | gm^-2 h | Day 1, Hour 8, each product | Eyes | Eyes |
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Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 5 weeks). AEs are reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device.
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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 exposure to the investigational product (including the 'No Lens wear' treatment) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr Global Brand Medical Affairs Lead, 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 | Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions |
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| Somofilcon A contact lenses | Device | Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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Delefilcon A contact lenses, narafilcon A contact lenses, and somofilcon A contact lenses worn bilaterally in cross-over fashion as randomized. Each product worn for one day, 8 hours minimum.
| OG001 | No Lens | One 8-hour day of no lens wear as part of the crossover sequence |
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| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | DAILIES TOTAL1 | All subjects exposed to DT1 contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized | 0 | 29 | 0 | 29 | 0 | 29 |
| EG002 | TruEye | All subjects exposed to TruEye contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized | 0 | 28 | 0 | 28 | 0 | 28 |
| EG003 | Clariti | All subjects exposed to clariti contact lenses worn for 8 hours during Period 1, 2, 3, or 4 as randomized | 0 | 29 | 0 | 29 | 0 | 29 |
| EG004 | No Lens | All subjects exposed to "No lens wear" for 8 hours during Period 1, 2, 3, or 4 as randomized | 0 | 29 | 0 | 29 | 0 | 29 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.