Myopia, Ametropia
Conditions
Keywords
Contact Lenses
Brief summary
The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.
Detailed description
The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.
Interventions
Commercially available silicone hydrogel contact lenses for daily disposable wear
Commercially available silicone hydrogel contact lenses for daily disposable wear
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
Key Inclusion Criteria: * Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board. * 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. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Current/previous PRECISION1 or INFUSE contact lens wearer. * Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator. * Routinely sleeps in contact lenses. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. No inferential testing was pre-specified for this endpoint. |
Countries
United States
Participant flow
Recruitment details
Study participants were recruited from 4 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all subjects/eyes exposed to any study lenses evaluated in this study.
Participants by arm
| Arm | Count |
|---|---|
| Precision1, Then Infuse Verofilcon A contact lenses worn first, with kalifilcon 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. | 32 |
| Infuse, Then Precision1 Kalifilcon 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 | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Wear Period (8 -0/+3 Days) | Adverse Event | 0 | 1 |
| First Wear Period (8 -0/+3 Days) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Precision1, Then Infuse | Total | Infuse, Then Precision1 |
|---|---|---|---|
| Age, Continuous | 34.9 years STANDARD_DEVIATION 8.2 | 35.0 years STANDARD_DEVIATION 8.2 | 35.1 years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 4 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 56 Participants | 28 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 | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 3 Participants | 0 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 | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 27 Participants | 50 Participants | 23 Participants |
| Region of Enrollment United States | 32 participants | 60 participants | 28 participants |
| Sex: Female, Male Female | 21 Participants | 39 Participants | 18 Participants |
| Sex: Female, Male Male | 11 Participants | 21 Participants | 10 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 / 60 | 0 / 116 | 0 / 58 | 0 / 120 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 116 | 0 / 58 | 0 / 120 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 116 | 0 / 58 | 0 / 120 | 0 / 60 |
Outcome results
Primary
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. No inferential testing was pre-specified for this endpoint.
Time frame: Day 8 (-0/+3 days), each study lens type
Population: Safety Analysis Set: All subjects/eyes exposed to any study lenses evaluated in this study with non-missing response
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Precision1 | Distance VA (logMAR) With Study Lenses | -0.14 logMAR | Standard Deviation 0.08 |
| Infuse | Distance VA (logMAR) With Study Lenses | -0.15 logMAR | Standard Deviation 0.07 |