Refractive Errors
Conditions
Keywords
Contact Lenses, Disposable
Brief summary
The purpose of this study is to compare the clinical performance of PRECISION1™ contact lenses to Clariti® 1 day contact lenses.
Detailed description
Subjects will be expected to attend 3 study visits and wear the study lenses daily for at least 10 hours per day. On the day prior to Visits 2 and 3, subjects will be expected to wear the study lenses for at least 16 hours. The total duration of subject participation 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 wearer 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. * Possess spectacles and 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 one of the days (day prior to each week 1 visit). * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Habitual PRECISION1, Clariti 1-Day, and DAILIES TOTAL1 contact lens wearers. * Any monovision and multifocal lens wearers. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Distance VA (logMAR) With Study Lenses | Day 8, each study lens type | Distance visual acuity (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. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 8 investigative sites in the United States.
Pre-assignment details
Of the 170 enrolled, 3 subjects were exited prior to randomization as screen failures. This reporting group includes all randomized subjects (167).
Participants by arm
| Arm | Count |
|---|---|
| PRECISION1, Then Clariti 1-Day Verofilcon A contact lenses worn first, with somofilcon A contact lenses worn second, as randomized. Each study lens type was worn bilaterally (in both eyes) for 8 days in a daily disposable modality. | 83 |
| Clariti 1-Day, Then PRECISION1 Somofilcon 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 days in a daily disposable modality. | 84 |
| Total | 167 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Wear Period (8 Days) | Lost to Follow-up | 0 | 1 |
| First Wear Period (8 Days) | Withdrawal by Subject | 1 | 0 |
| Second Wear Period (8 Days) | Protocol deviation, dispensed wrong powers | 1 | 0 |
Baseline characteristics
| Characteristic | PRECISION1, Then Clariti 1-Day | Clariti 1-Day, Then PRECISION1 | Total |
|---|---|---|---|
| Age, Continuous | 31.3 years STANDARD_DEVIATION 8.9 | 31.4 years STANDARD_DEVIATION 7.5 | 31.4 years STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants | 76 Participants | 154 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 12 Participants | 13 Participants | 25 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 69 Participants | 67 Participants | 136 Participants |
| Region of Enrollment United States | 83 participants | 84 participants | 167 participants |
| Sex: Female, Male Female | 54 Participants | 62 Participants | 116 Participants |
| Sex: Female, Male Male | 29 Participants | 22 Participants | 51 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 / 167 | 0 / 334 | 0 / 167 | 0 / 332 | 0 / 166 |
| other Total, other adverse events | 0 / 167 | 0 / 334 | 0 / 167 | 0 / 332 | 0 / 166 |
| serious Total, serious adverse events | 0 / 167 | 0 / 334 | 0 / 167 | 0 / 332 | 0 / 166 |
Outcome results
Primary
Least Squares Mean Distance VA (logMAR) With Study Lenses
Distance visual acuity (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.
Time frame: Day 8, each study lens type
Population: Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study with non-missing response (eye)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PRECISION1 | Least Squares Mean Distance VA (logMAR) With Study Lenses | -0.119 logMAR | Standard Error 0.0055 |
| Clariti 1-Day | Least Squares Mean Distance VA (logMAR) With Study Lenses | -0.122 logMAR | Standard Error 0.0055 |