Astigmatism
Conditions
Keywords
Contact Lens
Brief summary
Brief summary: Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double-masked (subject and investigator), repeated measures insertion study.
Detailed description
Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double-masked (subject and investigator), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria, subjects will be dispensed study lenses according to unique randomization tables that will be provided to each Investigator. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.
Interventions
DEVICEkalifilcon A Daily Disposable Toric
kalifilcon A Daily Disposable Toric
Acuvue Oasys 1-Day for Astigmatism
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
Yes
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
The subject is not eligible to participate in the study if the subject is: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Gaze Orientation | Assessed 5 minutes after lens insertion | Primary gaze orientation 5 minutes after lens insertion |
Countries
United States
Participant flow
Recruitment details
30 Subjects were screened for eligibility between August 11, 2023 and August 15, 2023.
Pre-assignment details
30 of 30 subjects were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Participants Received Kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism All 30 subjects that completed the study received both kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Participants Received Kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism |
|---|---|
| Age, Continuous | 47.5 years STANDARD_DEVIATION 12.48 |
| Race/Ethnicity, Customized Ethnicity : Hispanic or Latino | 0 Participants |
| Race/Ethnicity, Customized Ethnicity : Not Hispanic or Latino | 28 Participants |
| Race/Ethnicity, Customized Ethnicity : Unknown or Not Reported | 2 Participants |
| Race/Ethnicity, Customized Race : Asian | 1 Participants |
| Race/Ethnicity, Customized Race : Black or African American | 1 Participants |
| Race/Ethnicity, Customized Race : More than one race | 1 Participants |
| Race/Ethnicity, Customized Race : White | 27 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Primary Gaze Orientation
Primary gaze orientation 5 minutes after lens insertion
Time frame: Assessed 5 minutes after lens insertion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants Received Kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism | Primary Gaze Orientation | Acuvue Oasys 1-Day for Astigmatism at 5 min | 7.9 Degrees | Standard Deviation 13.54 |
| Participants Received Kalifilcon A Daily Disposable Toric and Acuvue Oasys 1-Day for Astigmatism | Primary Gaze Orientation | kalifilcon A toric lenses at 5 min | 2.4 Degrees | Standard Deviation 3.62 |