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The purpose of this study is to evaluate the performance of two commercially-available silicone hydrogel contact lenses in normal and low humidity environments after at least 7 days of wear.
After randomization to lens order, subjects attended study visits that included a 3 hour exposure to reduced humidity environment (20% relative humidity) and subsequent tear film assessments for each study lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AO1D, then AO | Other | Senofilcon A contact lenses with HydraLuxe™, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality. |
|
| AO, then AO1D | Other | Senofilcon A contact lenses, followed by senofilcon A contact lenses with HydraLuxe™. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Senofilcon A contact lenses with HydraLuxe™ | Device | Contact lenses worn during Period 1 or 2, as randomized |
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| Measure | Description | Time Frame |
|---|---|---|
| Tear Film Evaporation Rate in a Normal Environment After 10 ± 3 Days of Wear (Pre RH) | Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance. | Day 10 ± 3 days, each product |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH) | Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 6 hours of lens wear, including 3 hours of wear in a 20% reduced humidity environment (20% RH), after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Clinical Manager, GCRA Operations | Alcon Research | Study Director |
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Of the 84 enrolled, 1 subject was exited as a screen failure prior to randomization. One subject was discontinued after randomization but prior to study lenses parameter optimization. This reporting group includes all subjects exposed to habitual or study lenses (82).
Subjects were recruited from one study center located in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Habitual, AO1D, AO | Habitual contact lenses worn first (to understand the baseline performance in this population), followed by senofilcon A contact lenses with HydraLuxe™ in Period 1 and senofilcon A contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 10 days in a daily wear, daily disposable modality. |
| FG001 | Habitual, AO, AO1D | Habitual contact lenses worn first (to understand the baseline performance in this population), followed by senofilcon A contact lenses in Period 1, then senofilcon A contact lenses with HydraLuxe™ 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 analysis population includes all randomized subjects who were exposed to any study lenses used for parameter optimization, habitual lenses, or study lenses dispensed for 10-day wear (Full Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Habitual contact lenses worn first, followed by senofilcon A contact lenses with HydraLuxe™ and senofilcon 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 |
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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 in a Normal Environment After 10 ± 3 Days of Wear (Pre RH) | Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 3 hours of wear in a normal environment after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance. | Full Analysis Set. Number Analyzed is the number of eyes with non-missing response. | Posted | Mean | Standard Deviation | 10^-7g/cm^2/s | Day 10 ± 3 days, each product | Eyes | Eyes |
|
Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 39 days). AEs are reported as pre-treatment 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 | Pre-treatment | All subjects who consented to participate in the study prior to initiation of study treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Brand Lead, Global Medical Affairs, Vision Care | 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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| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| Senofilcon A contact lenses | Device | Contact lenses worn during Period 1 or 2, as randomized |
|
|
| Day 10 ± 3 days, each product |
| Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH) | MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed in a normal environment following 3 hours of wear. Higher values indicate less dry and more eye comfort. | Day 10 ± 3 days, each product |
| Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH) | MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed following 6 hours of wear including 3 hours in a reduced humidity environment (20% RH).. Higher values indicate less dry and more eye comfort. | Day 10 ± 3 days, each product |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 | ACUVUE OASYS 1-DAY | Senofilcon A contact lenses with HydraLuxe™ worn bilaterally for 10 days in a daily wear, daily disposable modality |
| OG001 | ACUVUE OASYS | Senofilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality |
|
|
| Secondary | Tear Film Evaporation Rate After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH) | Tear film evaporation rate (amount of tears that evaporates over a surface area per seconds) assessment was performed using the Oregon Health Sciences University Evaporometer. Measurements were taken on both the right and left eyes after 6 hours of lens wear, including 3 hours of wear in a 20% reduced humidity environment (20% RH), after 10 ± 3 days of lens wear. The temperature and humidity were measured within an air chamber around the ocular surface with the eyes opened and closed. The evaporation from the ocular surface was calculated as the difference between the evaporation rate of the skin taken during the closed eye measurement and the evaporation rate taken during the open eye measurement. The rate of evaporation was measured in g/cm2/sec for 2 humidity ranges. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance. | Full Analysis Set. Number Analyzed is the number of eyes with non-missing response. | Posted | Mean | Standard Deviation | 10^-7g/cm^2/s | Day 10 ± 3 days, each product | Eyes | Eyes |
|
|
|
| Secondary | Pre-Lens Tear Film Minimum Protected Area (MPA) in a Normal Environment After 10 ± 3 Days of Wear (Pre RH) | MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed in a normal environment following 3 hours of wear. Higher values indicate less dry and more eye comfort. | Full Analysis Set. Number Analyzed is the number of eyes with non-missing response. | Posted | Mean | Standard Deviation | percentage of contact lens surface area | Day 10 ± 3 days, each product | Eyes | Eyes |
|
|
|
| Secondary | Pre-Lens Tear Film MPA After 10 ± 3 Days of Wear and After 3 Hours Exposure to Reduced Humidity (Post RH) | MPA is the minimum area of the contact lens surface (expressed in %) that is protected by the tear film during the entire interblink period. Pre-lens tear film MPA was assessed following 6 hours of wear including 3 hours in a reduced humidity environment (20% RH).. Higher values indicate less dry and more eye comfort. | Full Analysis Set. Number Analyzed is the number of eyes with non-missing response. | Posted | Mean | Standard Deviation | percentage of contact lens surface area | Day 10 ± 3 days, each product | Eyes | Eyes |
|
|
|
| 0 |
| 84 |
| 0 |
| 84 |
| 0 |
| 84 |
| EG001 | Habitual Lenses | All subjects exposed to habitual contact lenses during Period 1 | 0 | 82 | 0 | 82 | 0 | 82 |
| EG002 | ACUVUE OASYS 1-DAY | All subjects exposed to ACUVUE OASYS 1-DAY contact lenses | 0 | 76 | 0 | 76 | 0 | 76 |
| EG003 | ACUVUE OASYS | All subjects exposed to ACUVUE OASYS contact lenses | 0 | 76 | 0 | 76 | 0 | 76 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.