Astigmatism
Conditions
Keywords
Contact Lens
Brief summary
Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), 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 masked), 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 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 Toric Lens
Kalifilcon A Daily Disposable Toric for Ametropia
DEVICETotal1 for Astigmatism
Total1 for Astigmatism
Precision1 for Astigmatism
DEVICEMyDay Toric
MyDay Toric
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
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 for 5 Minutes | 5 minutes after lens insertion | Primary gaze orientation is measured in degrees using a slit lamp and reticule. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Kalifilcon A Daily Disposable Toric, Total1, Precision1, and MyDay Toric. Participants received kalifilcon A daily disposable toric, Total1 for Astigmatism, Precision1 for Astigmatism, and MyDay Toric. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Kalifilcon A Daily Disposable Toric, Total1, Precision1, and MyDay Toric. |
|---|---|
| Age, Continuous Age 28 to 70 | 46.6 years STANDARD_DEVIATION 12.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 27 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 16 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 for 5 Minutes
Primary gaze orientation is measured in degrees using a slit lamp and reticule.
Time frame: 5 minutes after lens insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Kalifilcon A Daily Disposable Toric | Primary Gaze Orientation for 5 Minutes | 3.3 degrees | Standard Deviation 5.19 |
| Total1 for Astigmatism | Primary Gaze Orientation for 5 Minutes | 2.8 degrees | Standard Deviation 4.16 |
| Precision1 for Astigmatism | Primary Gaze Orientation for 5 Minutes | 2.4 degrees | Standard Deviation 3.96 |
| MyDay Toric | Primary Gaze Orientation for 5 Minutes | 3.6 degrees | Standard Deviation 5.45 |