Ametropia, Astigmatism, Refractive Errors
Conditions
Keywords
Contact Lenses, Disposable
Brief summary
The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.
Detailed description
Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. The total duration of subject participation will be up to 22 days.
Interventions
Soft contact lenses for optical correction of astigmatism
Soft contact lenses for optical correction of astigmatism
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Subjects will receive treatment based upon the randomized treatment sequence assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers. * Any spherical monovision and multifocal lens wearers. * Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Distance VA (logMAR) With Study Lenses | Day 8 (-0/+3 days), 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
Study participants were recruited from 8 investigative sites located in the United States.
Pre-assignment details
Of the 115 enrolled, 1 participant was exited from the study prior to randomization as a screen failure. This reporting group includes all subjects/eyes exposed to any study lenses evaluated in this study (114).
Participants by arm
| Arm | Count |
|---|---|
| P1fA, Then AMfA Verofilcon A toric contact lenses worn first, with etafilcon A toric 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. | 56 |
| AMfA, Then P1fA Etafilcon A toric contact lenses worn first, with verofilcon A toric 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. | 58 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Wear Period (8 -0/+3 Days) | Adverse Event | 1 | 0 |
| Second Wear Period (8 -0/+3 Days) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | P1fA, Then AMfA | AMfA, Then P1fA |
|---|---|---|---|
| Age, Continuous | 32.3 years STANDARD_DEVIATION 10.1 | 32.5 years STANDARD_DEVIATION 9.9 | 32.1 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 9 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 94 Participants | 47 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 23 Participants | 12 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 13 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 67 Participants | 31 Participants | 36 Participants |
| Region of Enrollment United States | 114 participants | 56 participants | 58 participants |
| Sex: Female, Male Female | 70 Participants | 31 Participants | 39 Participants |
| Sex: Female, Male Male | 44 Participants | 25 Participants | 19 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 / 114 | 0 / 228 | 0 / 114 | 0 / 226 | 0 / 113 |
| other Total, other adverse events | 0 / 114 | 0 / 228 | 0 / 114 | 0 / 226 | 0 / 113 |
| serious Total, serious adverse events | 0 / 114 | 0 / 228 | 1 / 114 | 0 / 226 | 0 / 113 |
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 (-0/+3 days), 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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| P1fA | Least Squares Mean Distance VA (logMAR) With Study Lenses | -0.08 logMAR | Standard Error 0.006 |
| AMfA | Least Squares Mean Distance VA (logMAR) With Study Lenses | -0.07 logMAR | Standard Error 0.006 |
Mixed effects repeated measures model