Habitual Soft Contact Lens Use
Conditions
Brief summary
Approximately 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, subjects will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.
Interventions
DEVICEkalifilcon A lenses
Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
DEVICEDalies Total 1
Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
DEVICEPrecision 1
Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
DEVICEBiotrue ONEday
Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
Sponsors
Bausch & Lomb Incorporated
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
* 18 years or older and have full legal capacity to volunteer. * Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * No active ocular disease or allergic conjunctivitis. * Not using any topical ocular medications. * Willing and able to follow instructions. * Signed a statement of informed consent.
Exclusion criteria
* Participating in a conflicting study in the opinion of the Investigator. * Considered by the Investigator to not be a suitable candidate for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surface Refractive Index Shifts at 5 Minutes | 5 minutes | Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units. |
| Surface Refractive Index Shifts at 10 Minutes | 10 minutes | Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units. |
| Surface Refractive Index Shifts at 15 Minutes | 15 minutes | Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units. |
Countries
United States
Participant flow
Recruitment details
There were 10 participants. Each of the 10 participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. All participants completed the study, therefore each participant wore kalifilcon A lens, Dailies Total 1, Precision 1, and Biotrue ONEday. The only way to show demography for each lens is to show the same information for 10 participants that completed kalifilcon A lens wear, the 10 participants that completed Dailies Total 1 wear, the 10 participants that completed Precision 1 wear, and the 10 participants that completed Biotrue ONEday wear, but there are 10 participants total, not the 40 that the demography table would show if the duplicate information is entered for each lens to which a participant was exposed. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 42.2 years STANDARD_DEVIATION 13.38 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Surface Refractive Index Shifts at 10 Minutes
Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
Time frame: 10 minutes
Population: Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. The surface refractive index was measured at each timepoint. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kalifilcon A Lenses | Surface Refractive Index Shifts at 10 Minutes | 1.4102 No units | Standard Deviation 0.00241 |
| Dailies Total 1 | Surface Refractive Index Shifts at 10 Minutes | 1.4267 No units | Standard Deviation 0.00113 |
| Precision 1 | Surface Refractive Index Shifts at 10 Minutes | 1.4182 No units | Standard Deviation 0.00286 |
| Biotrue ONEday | Surface Refractive Index Shifts at 10 Minutes | 1.3786 No units | Standard Deviation 0.0008 |
Primary
Surface Refractive Index Shifts at 15 Minutes
Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
Time frame: 15 minutes
Population: Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. The surface refractive index was measured at each timepoint. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kalifilcon A Lenses | Surface Refractive Index Shifts at 15 Minutes | 1.4105 No units | Standard Deviation 0.00163 |
| Dailies Total 1 | Surface Refractive Index Shifts at 15 Minutes | 1.4238 No units | Standard Deviation 0.00213 |
| Precision 1 | Surface Refractive Index Shifts at 15 Minutes | 1.4188 No units | Standard Deviation 0.00306 |
| Biotrue ONEday | Surface Refractive Index Shifts at 15 Minutes | 1.3793 No units | Standard Deviation 0.0015 |
Primary
Surface Refractive Index Shifts at 5 Minutes
Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
Time frame: 5 minutes
Population: Participants wore each lens type for 5, 10 and 15 minutes in a randomly assigned fashion. The surface refractive index was measured at each timepoint. All participants completed the study. All 10 participants completed kalifilcon A lens wear, all 10 participants completing Dailies Total 1 wear, all 10 participants completed Precision 1 wear, and all 10 participants completed Biotrue ONEday wear. There were 10 participants total who wore each lens type for 5, 10 and 15 minutes each.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kalifilcon A Lenses | Surface Refractive Index Shifts at 5 Minutes | 1.4102 No units | Standard Deviation 0.0022 |
| Dailies Total 1 | Surface Refractive Index Shifts at 5 Minutes | 1.4251 No units | Standard Deviation 0.00274 |
| Precision 1 | Surface Refractive Index Shifts at 5 Minutes | 1.4188 No units | Standard Deviation 0.0038 |
| Biotrue ONEday | Surface Refractive Index Shifts at 5 Minutes | 1.3788 No units | Standard Deviation 0.00157 |