Refractive Errors, Myopia
Conditions
Keywords
Daily disposable contact lenses
Brief summary
The primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.
Detailed description
Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.
Interventions
Spherical soft contact lenses for daily disposable wear
Spherical soft 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
Key Inclusion Criteria: * Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form. * Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months. * Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type. * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Any ocular condition that contraindicates contact lens wear. * Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity (VA) With Study Lenses | Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type | Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 4 investigative sites located in the United States.
Pre-assignment details
Of the 56 subjects enrolled in the study, 1 subject was discontinued after randomization and prior to exposure to the study lenses. This reporting group includes all randomized and exposed subjects (55).
Participants by arm
| Arm | Count |
|---|---|
| PRECISION1, Then Biotrue ONEday Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. | 27 |
| Biotrue ONEday, Then PRECISION1 Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality. | 28 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Wear Period (8 -0/+3 Days) | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | PRECISION1, Then Biotrue ONEday | Total | Biotrue ONEday, Then PRECISION1 |
|---|---|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 6.3 | 34.0 years STANDARD_DEVIATION 7.7 | 34.3 years STANDARD_DEVIATION 8.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 51 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 51 Participants | 26 Participants |
| Region of Enrollment United States | 27 participants | 55 participants | 28 participants |
| Sex: Female, Male Female | 20 Participants | 45 Participants | 25 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 3 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 | 0 / 55 | 0 / 110 | 0 / 55 | 0 / 108 | 0 / 54 |
| other Total, other adverse events | 0 / 55 | 0 / 110 | 0 / 55 | 0 / 108 | 0 / 54 |
| serious Total, serious adverse events | 0 / 55 | 0 / 110 | 0 / 55 | 0 / 108 | 0 / 54 |
Outcome results
Primary
Distance Visual Acuity (VA) With Study Lenses
Distance VA was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.
Time frame: Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type
Population: Safety Analysis Set with non-missing response
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRECISION1 | Distance Visual Acuity (VA) With Study Lenses | -0.13 logMAR | Standard Deviation 0.08 |
| Biotrue ONEday | Distance Visual Acuity (VA) With Study Lenses | -0.12 logMAR | Standard Deviation 0.08 |