Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to measure the coefficient of friction of three silicone hydrogel, daily disposable contact lenses after 16 hours of wear.
In this 3-treatment, 3-period, 6-sequence crossover study, each participant will wear all 3 products in randomized order, 1 product at a time, with a washout period of up to 7 days between treatment periods. Lenses will be collected for ex-vivo lubricity analysis. The ex-vivo lubricity analysis will be conducted under a separate non-clinical protocol.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TruEye, MyDay, clariti 1day | Other | Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 1 day (16 hours). |
|
| TruEye, clariti 1day, MyDay | Other | Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). |
|
| MyDay, TruEye, clariti 1day | Other | Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). |
|
| MyDay, clariti 1day, TruEye | Other | Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narafilcon A contact lenses | Device | Silicone hydrogel contact lenses for daily disposable wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Coefficient of Friction of Worn Lenses at 16 Hours | Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only. | Day 1, Hour 16, each product |
| Measure | Description | Time Frame |
|---|---|---|
| Average Coefficient of Friction of Unworn Lenses | Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. | Day 1 (each product) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, Vision Care, Global Medical Affairs | Alcon Research | Study Director |
Not provided
All enrolled participants (24)
Participants were recruited from three investigational centers located in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TruEye, MyDay, Clariti 1day | Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3 |
| FG001 | TruEye, Clariti 1day, MyDay | Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3 |
| FG002 | MyDay, TruEye, Clariti 1day | Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3 |
| FG003 | MyDay, Clariti 1day, TruEye | Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3 |
| FG004 | Clariti 1day, TruEye, MyDay | Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3 |
| FG005 | Clariti 1day, MyDay, TruEye | Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Wear Period (1 Day) |
| ||||||||||||||||
| Second Wear Period (1 Day) |
| ||||||||||||||||
| Third Wear Period (1 Day) |
|
Intention to treat, defined as the set of all randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TruEye, MyDay, Clariti 1day | Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3 |
| BG001 | TruEye, Clariti 1day, MyDay |
| 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 | Average Coefficient of Friction of Worn Lenses at 16 Hours | Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only. | Intention to treat participants with non-missing observations | Posted | Mean | Standard Deviation | unitless | Day 1, Hour 16, each product |
|
Adverse events (AEs) were collected for the duration of the study from the signing of informed consent (up to 17 days). This analysis population includes all participants exposed to investigational product.
AEs were defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs, whether or not related to the medical device, obtained through solicited and spontaneous comments from all exposed participants and reported based on the treatment received. Ocular AEs are presented for both eyes combined.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TruEye | Narafilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Affairs Franchise Head, Vision Care | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Clariti 1day, TruEye, MyDay | Other | Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). |
|
| Clariti 1day, MyDay, TruEye | Other | Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). |
|
|
| Stenfilcon A contact lenses | Device | Silicone hydrogel contact lenses for daily disposable wear |
|
|
| Somofilcon A contact lenses | Device | Silicone hydrogel contact lenses for daily disposable wear |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
| BG002 | MyDay, TruEye, Clariti 1day | Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3 |
| BG003 | MyDay, Clariti 1day, TruEye | Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3 |
| BG004 | Clariti 1day, TruEye, MyDay | Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3 |
| BG005 | Clariti 1day, MyDay, TruEye | Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3 |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Clariti 1day | Somofilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3 |
|
|
| Secondary | Average Coefficient of Friction of Unworn Lenses | Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. | Intention to treat participants with non-missing observations | Posted | Mean | Standard Deviation | unitless | Day 1 (each product) | contact lenses | Participants |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | MyDay | Stenfilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3 | 0 | 24 | 0 | 24 |
| EG002 | Clariti 1day | Somofilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3 | 0 | 24 | 0 | 24 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.