Myopia
Conditions
Brief summary
The objective of this study is to evaluate the product performance of kalifilcon A, compared to the Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses when worn by current soft contact lens wearers on a daily disposable wear basis.
Interventions
DEVICEkalifilcon A
kalifilcon A daily disposable contact lens
DEVICEdelefilcon A
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
DEVICEsenofilcon A
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent. * myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye. * correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution \[logMAR\]) or better (2 meters distance, high-contrast chart) in each eye. * free of any anterior segment disorders. * adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks. * access to internet connection and personal email to send/receive emails. * habitually wear either Alcon's Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night & Day, Bausch + Lomb's PureVision 2, Bausch + Lomb ULTRA, CooperVision's Biofinity, Johnson & Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft contact lenses.
Exclusion criteria
* participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation. * have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months. * have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study. * using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses. * refractive astigmatism of greater than 0.75 D in either eye. * anisometropia (spherical equivalent) of greater than 2.00 D. * amblyopic. * have had any corneal surgery (e.g., refractive surgery).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in logMAR Contact Lens Visual Acuity | Baseline, 2 Week Follow up | logMAR is the logarithm of the minim angle of resolution |
| Percentage of Participants in the Test Lens Group Agreeing With the Statement Are Comfortable Throughout the Day | 2 Week Follow up | — |
| Percentage of Participants in the Test Lens Group Agreeing With the Statement Provide Clear Vision Throughout the Day | 2 Week Follow up | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Kalifilcon A kalifilcon A daily disposable contact lens
kalifilcon A: kalifilcon A daily disposable contact lens | 398 |
| Delefilcon A DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses | 202 |
| Senofilcon A Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens | 205 |
| Total | 805 |
Baseline characteristics
| Characteristic | Kalifilcon A | Delefilcon A | Senofilcon A | Total |
|---|---|---|---|---|
| Age, Continuous | 30.5 years STANDARD_DEVIATION 5.72 | 30.0 years STANDARD_DEVIATION 6.11 | 29.3 years STANDARD_DEVIATION 5.78 | 30.3 years STANDARD_DEVIATION 5.95 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 56 Participants | 30 Participants | 26 Participants | 112 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 17 Participants | 25 Participants | 89 Participants |
| Race (NIH/OMB) More than one race | 10 Participants | 3 Participants | 7 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 4 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 281 Participants | 147 Participants | 146 Participants | 574 Participants |
| Sex: Female, Male Female | 262 Participants | 125 Participants | 140 Participants | 527 Participants |
| Sex: Female, Male Male | 136 Participants | 77 Participants | 65 Participants | 278 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 398 | 0 / 202 | 0 / 205 |
| other Total, other adverse events | 0 / 398 | 0 / 202 | 0 / 205 |
| serious Total, serious adverse events | 0 / 398 | 0 / 202 | 0 / 205 |
Outcome results
Primary
Mean Change in logMAR Contact Lens Visual Acuity
logMAR is the logarithm of the minim angle of resolution
Time frame: Baseline, 2 Week Follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kalifilcon A | Mean Change in logMAR Contact Lens Visual Acuity | -0.056 logMAR | Standard Deviation 0.0727 |
| Delefilcon A | Mean Change in logMAR Contact Lens Visual Acuity | -0.069 logMAR | Standard Deviation 0.0733 |
| Senofilcon A | Mean Change in logMAR Contact Lens Visual Acuity | -0.069 logMAR | Standard Deviation 0.0718 |
Primary
Percentage of Participants in the Test Lens Group Agreeing With the Statement Are Comfortable Throughout the Day
Time frame: 2 Week Follow up
Population: Participants with 2 week follow up and responded to the question.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Kalifilcon A | Percentage of Participants in the Test Lens Group Agreeing With the Statement Are Comfortable Throughout the Day | 317 Participants |
| Delefilcon A | Percentage of Participants in the Test Lens Group Agreeing With the Statement Are Comfortable Throughout the Day | 160 Participants |
| Senofilcon A | Percentage of Participants in the Test Lens Group Agreeing With the Statement Are Comfortable Throughout the Day | 166 Participants |
Primary
Percentage of Participants in the Test Lens Group Agreeing With the Statement Provide Clear Vision Throughout the Day
Time frame: 2 Week Follow up
Population: Participants with 2 week follow up and responded to the question.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Kalifilcon A | Percentage of Participants in the Test Lens Group Agreeing With the Statement Provide Clear Vision Throughout the Day | 358 Participants |
| Delefilcon A | Percentage of Participants in the Test Lens Group Agreeing With the Statement Provide Clear Vision Throughout the Day | 184 Participants |
| Senofilcon A | Percentage of Participants in the Test Lens Group Agreeing With the Statement Provide Clear Vision Throughout the Day | 188 Participants |