Refractive Errors
Conditions
Keywords
Contact Lenses
Brief summary
The purpose of this study is to compare the clinical performance of PRECISION1 contact lenses with Biotrue contact lenses.
Detailed description
Subjects will be expected to attend 3 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over an 8-day period for each study lens type. The total duration of a subject's participation in the study will be 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: * Successful wear of spherical soft contact lenses with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. * Willing to wear habitual spectacles for vision correction when study lenses are not worn, as needed. * Willing to wear contact lenses for at least 16 hours on the day prior to Visit 2 and the day prior to Visit 3. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Participation in a clinical trial within the previous 30 days or currently enrolled in any clinical trial. * Habitual PRECISION1, Biotrue, and DAILIES TOTAL1 contact lens wear. * Monovision and multifocal lens wear. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Distance Visual Acuity (VA) With Study Lenses | Day 8 (-0/+3 days), each study lens type | Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 8 investigative sites in the US.
Pre-assignment details
Of the 129 enrolled, 3 subjects were screen failures prior to randomization. This reporting group includes all randomized subjects, as treated (126).
Participants by arm
| Arm | Count |
|---|---|
| PRECISION1, Then Biotrue Verofilcon A contact lenses worn first, with nesofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses was worn each day. | 62 |
| Biotrue, Then PRECISION1 Nesofilcon A contact lenses worn first, with verofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) at least 10 hours per day for 8 -0/+3 days. A fresh pair of lenses was worn each day. | 64 |
| Total | 126 |
Baseline characteristics
| Characteristic | Biotrue, Then PRECISION1 | Total | PRECISION1, Then Biotrue |
|---|---|---|---|
| Age, Continuous | 33.5 years STANDARD_DEVIATION 7.3 | 32.4 years STANDARD_DEVIATION 7.8 | 31.4 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 15 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 58 Participants | 110 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Missing data | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Multi-racial | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 61 Participants | 118 Participants | 57 Participants |
| Sex: Female, Male Female | 42 Participants | 84 Participants | 42 Participants |
| Sex: Female, Male Male | 22 Participants | 42 Participants | 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 126 | 0 / 252 | 0 / 126 | 0 / 252 | 0 / 126 |
| other Total, other adverse events | 0 / 126 | 0 / 252 | 0 / 126 | 0 / 252 | 0 / 126 |
| serious Total, serious adverse events | 0 / 126 | 0 / 252 | 0 / 126 | 0 / 252 | 0 / 126 |
Outcome results
Primary
Least Squares Mean Distance Visual Acuity (VA) With Study Lenses
Visual Acuity (VA) was collected for each eye individually with study lenses in place using a letter chart. VA was measured in logarithm of the minimum angle of resolution (logMAR). A logMAR value of 0 corresponds to 20/20 Snellen acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Time frame: Day 8 (-0/+3 days), each study lens type
Population: Full Analysis Set: All randomized subjects who were exposed to any study lenses evaluated in this clinical study with data at Day 8.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PRECISION1 | Least Squares Mean Distance Visual Acuity (VA) With Study Lenses | -0.13 logMAR | Standard Error 0.006 |
| Biotrue | Least Squares Mean Distance Visual Acuity (VA) With Study Lenses | -0.13 logMAR | Standard Error 0.006 |