Refractive Error
Conditions
Keywords
DACP, DAILIES® AquaComfort Plus, Tear film stability, NIK-BUT
Brief summary
The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.
Interventions
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
* Must sign an Informed Consent form; * Adapted, current soft contact lens wearer; * Required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (D)); * Cylinder ≤ -1.00 D in both eyes at Visit 1; * Vision correctable to 0.1 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye at distance with pre-study lenses at Visit 1; * Willing to wear study lenses up to 12 hours and attend all study visits; * Able to be successfully fitted with study lenses; * Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * Any 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 1 eye with functional vision) or fit with only 1 lens; * Any abnormal ocular condition observed during Visit 1; * History of herpetic keratitis, ocular surgery, or irregular cornea; * Pregnant or lactating; * Participation in any clinical study within 30 days of Visit 1; * Current MyDay® or DAILIES® AquaComfort Plus® lens wearer; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear | Day 1, Hour 12, each period | The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear | Hour 12 | The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated. |
Countries
Germany
Participant flow
Recruitment details
Subjects were recruited from 1 investigational site located in Germany.
Participants by arm
| Arm | Count |
|---|---|
| Overall Nelfilcon A and stenfilcon A contact lenses worn for 12 hours each in Period 1 and 2 as randomized | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 25.3 years STANDARD_DEVIATION 3.11 |
| Region of Enrollment Germany | 31 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 |
Outcome results
Primary
Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear
The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.
Time frame: Day 1, Hour 12, each period
Population: This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DACP | Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear | 22.84 seconds | Standard Deviation 3.299 |
| MyDay | Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear | 22.87 seconds | Standard Deviation 3.026 |
Secondary
Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear
The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The slope of the regression line (distorted areas vs. time) was calculated. A slower speed (higher number) indicates a more stable tear film. The right eye was evaluated.
Time frame: Hour 12
Population: This analysis population includes all randomized subjects who did not meet the critical deviation criteria as specified in the Deviations and Evaluability Plan.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DACP | Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear | 0.3 percent distortion per second | Standard Deviation 0.38 |
| MyDay | Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear | 0.2 percent distortion per second | Standard Deviation 0.23 |