Contact Lens Wearer
Conditions
Brief summary
This objective of this clinical study aims to confirm whether multiple kalifilcon A daily disposable toric contact lenses are providing the intended level of spherical aberration correction when worn.
Interventions
DEVICEkalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D
kalifilcon A Daily Disposable Toric LD213001 lens
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent. 2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. 3. Have no active ocular disease or allergic conjunctivitis. 4. Not be using any topical ocular medications. 5. Be willing and able to follow instructions. 6. Have signed a statement of informed consent.
Exclusion criteria
1. Participating in a conflicting study in the opinion of the Investigator. 2. Considered by the Investigator to not be a suitable candidate for participation. 3. A women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions: she is currently pregnant, she plans to become pregnant during the study, she is breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spherical Aberration Measurement | 60 minutes | Spherical aberration (SA) occurs when light rays entering at different points of a spherical lens are not focused to the same point of the optical axis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visibility of Toric Etch Mark by the Investigator | 60 minutes | Number of lenses the investigator could identify the toric etch mark |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Kalifilcon A Daily Disposable Toric LD213001 Lens kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D
kalifilcon A Daily Disposable Toric LD213001 lens in SKUs +6D, +3D, 0D, -3D, -6D, and -9D: kalifilcon A Daily Disposable Toric LD213001 lens | 75 |
| Total | 75 |
Baseline characteristics
| Characteristic | Kalifilcon A Daily Disposable Toric LD213001 Lens | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 75 Participants | — |
| Age, Continuous | 49.2 Years STANDARD_DEVIATION 11.27 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 75 participants | — |
| Sex: Female, Male Female | 32 Participants | — |
| Sex: Female, Male Male | 43 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 75 |
| other Total, other adverse events | 0 / 75 |
| serious Total, serious adverse events | 0 / 75 |
Outcome results
Primary
Spherical Aberration Measurement
Spherical aberration (SA) occurs when light rays entering at different points of a spherical lens are not focused to the same point of the optical axis.
Time frame: 60 minutes
Population: 30 eyes wore the +3D, 0D, -3D, -6D, and -9D contact lenses. 26 eyes wore the +6D contact lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens | Spherical Aberration Measurement | T04 (kali -3D) | 0.052 microns | Standard Deviation 0.145 |
| Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens | Spherical Aberration Measurement | T05 (kali -6D) | 0.062 microns | Standard Deviation 0.158 |
| Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens | Spherical Aberration Measurement | T01 (kali +6D) | 0.162 microns | Standard Deviation 0.187 |
| Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens | Spherical Aberration Measurement | T02 (kali +3D) | 0.090 microns | Standard Deviation 0.12 |
| Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens | Spherical Aberration Measurement | T03 (kali 0D) | 0.017 microns | Standard Deviation 0.133 |
| Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens | Spherical Aberration Measurement | T06 (kali -9D) | 0.102 microns | Standard Deviation 0.164 |
Secondary
Visibility of Toric Etch Mark by the Investigator
Number of lenses the investigator could identify the toric etch mark
Time frame: 60 minutes
Population: 30 eyes wore the +3D, 0D, -3D, -6D, and -9D contact lenses. 26 eyes wore the +6D contact lenses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens | Visibility of Toric Etch Mark by the Investigator | T01 kali +6D | 26 Lenses |
| Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens | Visibility of Toric Etch Mark by the Investigator | T02 kali +3D | 30 Lenses |
| Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens | Visibility of Toric Etch Mark by the Investigator | T03 kali +0D | 30 Lenses |
| Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens | Visibility of Toric Etch Mark by the Investigator | T04 kali -3D | 30 Lenses |
| Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens | Visibility of Toric Etch Mark by the Investigator | T05 kali -6D | 30 Lenses |
| Spherical Aberration of Kalifilcon A Daily Disposable Toric LD213001 Lens | Visibility of Toric Etch Mark by the Investigator | T06 kali -9D | 30 Lenses |