Refractive Error
Conditions
Keywords
Contact lenses, Lubricity
Brief summary
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.
Detailed description
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.
Interventions
Silicone hydrogel contact lenses for daily disposable wear
Silicone hydrogel contact lenses for daily disposable wear
Silicone hydrogel contact lenses for daily disposable wear
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must sign an informed consent form. * Soft contact lens wearer (both eyes). * Willing to wear study lenses at least 16 waking hours and attend all study visits. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear. * Use of systemic or ocular medications for which contact lens wear could be contraindicated. * Use of artificial tears and rewetting drops during the study. * Monocular (only 1 eye with functional vision) or fit with only 1 lens. * History of herpetic keratitis, ocular surgery, or irregular cornea. * Pregnant. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Coefficient of Friction of Worn Lenses at 16 Hours | Day 1, Hour 16, each product | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Coefficient of Friction of Unworn Lenses | Day 1 (each product) | 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. |
Participant flow
Recruitment details
Participants were recruited from three investigational centers located in the United States.
Pre-assignment details
All enrolled participants (24)
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| 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 | 4 |
| 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 | 4 |
| 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 | 4 |
| 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 | 4 |
| 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 | 4 |
| Total | 24 |
Baseline characteristics
| Characteristic | TruEye, MyDay, Clariti 1day | TruEye, Clariti 1day, MyDay | MyDay, TruEye, Clariti 1day | MyDay, Clariti 1day, TruEye | Clariti 1day, TruEye, MyDay | Clariti 1day, MyDay, TruEye | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 34.0 years STANDARD_DEVIATION 9.6 | 27.5 years STANDARD_DEVIATION 4 | 33.0 years STANDARD_DEVIATION 7.3 | 35.3 years STANDARD_DEVIATION 4.6 | 26.3 years STANDARD_DEVIATION 6.2 | 24.3 years STANDARD_DEVIATION 2.4 | 30.0 years STANDARD_DEVIATION 6.9 |
| Age, Customized 18-64 years | 4 participants | 4 participants | 4 participants | 4 participants | 4 participants | 4 participants | 24 participants |
| Age, Customized ≥65 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 4 Participants | 2 Participants | 15 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
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.
Time frame: Day 1, Hour 16, each product
Population: Intention to treat participants with non-missing observations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TruEye | Average Coefficient of Friction of Worn Lenses at 16 Hours | 0.0602 unitless | Standard Deviation 0.00474 |
| MyDay | Average Coefficient of Friction of Worn Lenses at 16 Hours | 0.0576 unitless | Standard Deviation 0.00338 |
| Clariti 1day | Average Coefficient of Friction of Worn Lenses at 16 Hours | 0.0578 unitless | Standard Deviation 0.00439 |
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.
Time frame: Day 1 (each product)
Population: Intention to treat participants with non-missing observations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TruEye | Average Coefficient of Friction of Unworn Lenses | 0.0571 unitless | Standard Deviation 0.00324 |
| MyDay | Average Coefficient of Friction of Unworn Lenses | 0.0571 unitless | Standard Deviation 0.0026 |
| Clariti 1day | Average Coefficient of Friction of Unworn Lenses | 0.0552 unitless | Standard Deviation 0.00305 |