Refractive Error
Conditions
Keywords
Contact lenses, Myopia, Near-sighted, Daily disposable
Brief summary
The purpose of this study is to obtain on-eye performance data to inform contact lens product development and to further evaluate product performance in the intended population.
Detailed description
The expected duration of subject participation in the study is approximately 20 days with 3 scheduled visits. Each subject will evaluate the test contact lenses compared to 1 of 3 commercially available contact lenses.
Interventions
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand and must sign an approved Informed Consent Form * Successfully wears daily disposable spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months * Best Corrected Visual Acuity of 20/25 Snellen or better in each eye * Willing to stop wearing habitual contact lenses for the duration of study participation * Other protocol-defined inclusion criteria may apply
Exclusion criteria
* Any eye condition, surgery, disease, or use of medication that contraindicates contact lens wear, as determined by the Investigator. * Routinely sleeps in habitual contact lenses * Currently wears Oasys 1-Day, MyDay, or Moist contact lenses * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Quality of Vision | Day 8, each product | Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked Thinking back over the last week, please rate our study lenses. Rate eyes together. No formal hypotheses was conducted; hence no inferential testing was performed. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 3 investigational sites located in the United States.
Pre-assignment details
Of the 68 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (66).
Participants by arm
| Arm | Count |
|---|---|
| Overall Verofilcon A contact lenses with corresponding control product (senofilcon A, stenfilcon A, or etafilcon) worn during Period 1 and Period 2 in a crossover assignment, as randomized. | 66 |
| Total | 66 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 32.9 years STANDARD_DEVIATION 9.1 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized White | 56 Participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 20 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 | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Overall Quality of Vision
Overall quality of vision was collected binocularly and rated on a 10-point scale with 1 = poor to 10 = excellent. Subjects were asked Thinking back over the last week, please rate our study lenses. Rate eyes together. No formal hypotheses was conducted; hence no inferential testing was performed.
Time frame: Day 8, each product
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DD T2 (Sequence 1 and 2) | Overall Quality of Vision | 8.5 units on a scale | Standard Deviation 1.4 |
| Oasys 1-Day (Sequence 1 and 2) | Overall Quality of Vision | 9.2 units on a scale | Standard Deviation 1.3 |
| DD T2 (Sequence 3 and 4) | Overall Quality of Vision | 8.8 units on a scale | Standard Deviation 1.8 |
| MyDay (Sequence 3 and 4) | Overall Quality of Vision | 9.4 units on a scale | Standard Deviation 0.8 |
| DD T2 (Sequence 5 and 6) | Overall Quality of Vision | 9.2 units on a scale | Standard Deviation 1.1 |
| Moist (Sequence 5 and 6) | Overall Quality of Vision | 8.8 units on a scale | Standard Deviation 1.7 |