Refractive Error
Conditions
Keywords
DT1, DAILIES TOTAL1®, Lubricity
Brief summary
The primary objective of the study is to demonstrate that the lubricity of DAILIES TOTAL1® (DT1) lenses after 16 hours of wear is equivalent to the lubricity of unworn DT1 lenses.
Detailed description
In this study, participants wore study lenses for 2 specified time periods (16 hours and 15 minutes, treatment sequence randomized) following which lenses were collected for ex vivo lubricity analysis. The ex vivo lubricity analysis was evaluated under a separate non-clinical protocol.
Interventions
Silicone hydrogel contact lenses
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
* Willing and able to sign Informed Consent document. * Adapted, current soft contact lens wearer. * Requires contact lens powers within the specified range of -0.50 diopters (D) to -10.00D. * Cylinder between 0.00D and -1.00D (inclusive) in both eyes at Visit 1 manifest refraction. * Vision correctable to 20/25 or better in each eye at distance with study lenses. * Willing to wear study lenses at least 16 waking hours in one day and attend all study visits. * Able to be successfully fitted with study lenses. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any ocular infection, inflammation, abnormality or active disease that would contraindicate contact lens wear, as determined by the Investigator. * Use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator. * Use of artificial tears and rewetting drops during the study. * Monocular (only one eye with functional vision) or fit with only one lens. * Any abnormal ocular condition observed during the Visit 1 slit lamp examination. * History of herpetic keratitis, ocular surgery, or irregular cornea. * Pregnant. * Participation in any clinical study within 30 days of Visit 1. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn | Day 1 (for each period), 16 hours | Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF 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 at 15 Minutes | Day 1 (for each period), 15 minutes | Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only. |
Participant flow
Recruitment details
Participants were recruited from 1 study center located in the US.
Pre-assignment details
This reporting group includes all randomized participants (15).
Participants by arm
| Arm | Count |
|---|---|
| Overall Delefilcon A contact lenses worn during Period 1 and Period 2 | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2, Second Wear | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 10.91 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn
Worn contact lenses were removed from the participant's eye. The CF was calculated and compared to the CF for unworn contact lenses. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
Time frame: Day 1 (for each period), 16 hours
Population: This analysis population includes all participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16 Hours | Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn | 0.0394 unitless | Standard Deviation 0.0015 |
| Unworn | Average Coefficient of Friction (CF) at 16 Hours Compared to Unworn | 0.0396 unitless | Standard Deviation 0.0027 |
Secondary
Average Coefficient of Friction at 15 Minutes
Worn contact lenses were removed from the participant's eye and the CF was calculated. A lower CF may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
Time frame: Day 1 (for each period), 15 minutes
Population: This analysis population includes all participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16 Hours | Average Coefficient of Friction at 15 Minutes | 0.0392 unitless | Standard Deviation 0.0017 |