Refractive Error
Conditions
Keywords
contact lens, silicone hydrogel, daily disposable, visual acuity
Brief summary
The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.
Interventions
DEVICEFID122819 contact lenses
Investigational 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)
Masking description
Alcon Observer and Sponsor personnel were also masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand and sign an IRB-approved Informed Consent Form; * Successful wear of 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: * Manifest cylinder of ≤ 0.75 diopter (D) in each eye; * Best corrected visual acuity (BCVA) of 20/25 or better in each eye; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator; * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator; * History of refractive surgery or plan to have refractive surgery during the study; * Ocular or intraocular surgery within the previous 12 months or planned during the study; * Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear; * Any previous or current wear of MYDAY; * Habitually wearing monovision or multifocal lenses during the last 3 months; * Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment; * Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity (VA) | Baseline/Dispense (Day 1), Week 1, each product | VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 3 study centers located in the United States.
Pre-assignment details
Of the 54 enrolled, 3 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (51).
Participants by arm
| Arm | Count |
|---|---|
| Overall FID122819 and stenfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment. | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2, Second Week of Wear | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 32.5 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
Primary
Visual Acuity (VA)
VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.
Time frame: Baseline/Dispense (Day 1), Week 1, each product
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FID112819 | Visual Acuity (VA) | Dispense | -0.08 logMAR | Standard Deviation 0.06 |
| FID112819 | Visual Acuity (VA) | Week 1 | -0.09 logMAR | Standard Deviation 0.06 |
| Stenfilcon A | Visual Acuity (VA) | Dispense | -0.09 logMAR | Standard Deviation 0.06 |
| Stenfilcon A | Visual Acuity (VA) | Week 1 | -0.09 logMAR | Standard Deviation 0.06 |