Ametropia, Astigmatism, Myopia
Conditions
Keywords
Contact lenses, Vision, Eye sight
Brief summary
The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).
Detailed description
Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 days.
Interventions
Soft contact lenses for optical correction of ametropia and astigmatism
DEVICEStenfilcon A toric soft contact lenses
Soft contact lenses for optical correction of ametropia and astigmatism
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 wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. * Able to wear contact lenses within a range of sphere & cylinder power and axes. * Willing to NOT use rewetting/lubricating drops at any time during the study. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Current or previous P1fA and MDT habitual lens wearers. * Monovision and multifocal lens wearers. * Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Means Distance Visual Acuity With Study Lenses at Week 1 | Day 8 of each study lens type worn during the corresponding crossover period | 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. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 11 investigative sites located in the United States.
Pre-assignment details
Of the 153 enrolled, 1 participant was exited prior to randomization as a screen failure. This reporting group includes all randomized participants (152).
Participants by arm
| Arm | Count |
|---|---|
| P1fA, Then MDT Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type was worn for 8 (-0/+3) days for at least 10 hours per day. Lenses were removed nightly and disposed of after a single use. | 77 |
| MDT, Then P1fA Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type was worn for 8 (-0/+3) days for at least 10 hours per day. Lenses were removed nightly and disposed of after a single use. | 75 |
| Total | 152 |
Baseline characteristics
| Characteristic | MDT, Then P1fA | Total | P1fA, Then MDT |
|---|---|---|---|
| Age, Continuous | 34.3 years STANDARD_DEVIATION 8.6 | 34.4 years STANDARD_DEVIATION 9 | 34.6 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 21 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 131 Participants | 65 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 10 Participants | 5 Participants |
| Race/Ethnicity, Customized Multi-Racial | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 66 Participants | 132 Participants | 66 Participants |
| Region of Enrollment United States | 75 participants | 152 participants | 77 participants |
| Sex: Female, Male Female | 46 Participants | 94 Participants | 48 Participants |
| Sex: Female, Male Male | 29 Participants | 58 Participants | 29 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 / 152 | 0 / 304 | 0 / 152 | 0 / 302 | 0 / 151 |
| other Total, other adverse events | 0 / 152 | 0 / 304 | 0 / 152 | 0 / 302 | 0 / 151 |
| serious Total, serious adverse events | 0 / 152 | 0 / 304 | 0 / 152 | 0 / 302 | 0 / 151 |
Outcome results
Primary
Least Squares Means Distance Visual Acuity With Study Lenses at Week 1
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. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.
Time frame: Day 8 of each study lens type worn during the corresponding crossover period
Population: Full Analysis Set with data at visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PRECISION1 for Astigmatism (P1fA) | Least Squares Means Distance Visual Acuity With Study Lenses at Week 1 | -0.11 logMAR | Standard Error 0.005 |
| MyDay Toric (MDT) | Least Squares Means Distance Visual Acuity With Study Lenses at Week 1 | -0.10 logMAR | Standard Error 0.005 |