Refractive Error
Conditions
Keywords
Contact lenses
Brief summary
The purpose of this study is to evaluate the functional vision of 2 daily disposable silicone hydrogel contact lenses using Time Controlled Visual Acuity (TCVA) measurements at high luminance and high contrast after 10+/-3 days of wear post 3 hour exposure to a reduced humidity environment.
Detailed description
After randomization, participants attended a baseline visit to include a 3 hour exposure to reduced humidity environment. The participant's habitual lenses were worn for the baseline visit.
Interventions
Contact lenses worn during Period 1 or 2, as randomized
Contact lenses worn during Period 1 or 2, as randomized
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must sign informed consent form. * Adapted, current soft silicone hydrogel daily disposable contact lens wearer during the last 2 months. * Willing to wear lenses every day or at least 5 days per week 6 hours per day. * Willing to discontinue artificial tears and rewetting drops usage on the days of study visits. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Monocular (only 1 eye with functional vision) or fit with only 1 lens. * Pregnant or lactating. * Current MyDay™ or 1DAY ACUVUE® TruEye® lens wearer. * Any abnormal ocular condition as specified in the protocol. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10 | Day 10, each product | High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10 | Day 10, each product | High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis. |
Participant flow
Recruitment details
Participants were enrolled from 1 investigative site located in the United Kingdom.
Pre-assignment details
Of the 66 enrolled participants, 2 participants were discontinued prior to randomization. This reporting group includes all randomized participants (64).
Participants by arm
| Arm | Count |
|---|---|
| Overall Habitual contact lenses worn first, followed by stenfilcon A contact lenses and narafilcon A contact lenses in Periods 1 and 2 as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality. | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Habitual, 10 Days of Wear | Withdrawal by Subject | 1 | 1 |
| Period 1, 10 Days of Wear | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 33.8 years STANDARD_DEVIATION 9.71 |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 66 | 5 / 32 | 0 / 32 | 0 / 60 | 0 / 61 |
| serious Total, serious adverse events | 0 / 66 | 0 / 32 | 0 / 32 | 1 / 60 | 1 / 61 |
Outcome results
Primary
High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10
High contrast TCVA was assessed after 3 hours exposure to reduced humidity environment. TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.
Time frame: Day 10, each product
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyDay | High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10 | 0.453 VA unit | Standard Deviation 0.673 |
| 1DAVTE | High Contrast Time-Controlled Visual Acuity (TCVA) (VA Unit) Post-Exposure to Reduced Humidity at Day 10 | 0.341 VA unit | Standard Deviation 0.781 |
Secondary
High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10
High contrast TCVA was assessed after 3 hours exposure to normal environment and prior to exposure to reduced humidity environment. Both eyes contributed to the analysis.
Time frame: Day 10, each product
Population: Intent to Treat Subjects
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MyDay | High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10 | 0.614 VA unit | Standard Deviation 0.689 |
| 1DAVTE | High Contrast TCVA (VA Unit) Pre-Exposure to Reduced Humidity at Day 10 | 0.700 VA unit | Standard Deviation 0.777 |