Astigmatism
Conditions
Brief summary
The objective is to evaluate the fit characteristics (primary gaze orientation, rotational recovery, and movement) of kalifilcon A daily disposable toric lenses as compared to commercially available Ultra for Astigmatism lenses.
Interventions
DEVICEkalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
DEVICECommercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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. 2. Considered by the Investigator to not be a suitable candidate for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | 3 minutes | Primary gaze orientation is measured in degrees. Measurement Description: Primary gaze is when the patient is looking straight ahead. Orientation refers to how much the contact lens is rotated on the eye. Primary gaze orientation of the contact lens is measured in degrees at the slit-lamp (microscope) using a reticle (protractor). Lens orientation was measured in primary gaze in 5-degree increments. Negative values indicate the contact lens was rotated in the temporal direction. Positive values indicate the contact lens was rotated in the nasal direction. The greater the value (positive or negative) the more the lens is rotated. The absolute value was calculated for all the measurements. The absolute values were used to calculate the mean primary gaze orientation after 3 minutes of contact lens wear. Criteria: P-values ≤0.05 will be considered statistically significant. |
Countries
United States
Participant flow
Recruitment details
There are a total of 14 study lens types (8 test contact lenses and 6 comparators contact lenses). Each study lens type will be worn once for approximately 10 minutes.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses Participants were given a total of 14 study lens types (8 kalifilcon A Daily Disposable Toric LD213001 Contact Lenses and 6 Commercially available Ultra for Astigmatism Contact Lenses).
Each study lens type will be worn once for approximately 10 minutes. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 30 Participants | — |
| Age, Continuous | 43.8 Years STANDARD_DEVIATION 13.22 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 13 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
Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees
Primary gaze orientation is measured in degrees. Measurement Description: Primary gaze is when the patient is looking straight ahead. Orientation refers to how much the contact lens is rotated on the eye. Primary gaze orientation of the contact lens is measured in degrees at the slit-lamp (microscope) using a reticle (protractor). Lens orientation was measured in primary gaze in 5-degree increments. Negative values indicate the contact lens was rotated in the temporal direction. Positive values indicate the contact lens was rotated in the nasal direction. The greater the value (positive or negative) the more the lens is rotated. The absolute value was calculated for all the measurements. The absolute values were used to calculate the mean primary gaze orientation after 3 minutes of contact lens wear. Criteria: P-values ≤0.05 will be considered statistically significant.
Time frame: 3 minutes
Population: Measurement Description: Lens orientation (in 5-degree increments) was measured in primary gaze (nasal = +, temporal = -)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | T01 | 1.3 degrees | Standard Deviation 3.92 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | C01 | 3.3 degrees | Standard Deviation 7.47 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | T02 | 2.0 degrees | Standard Deviation 4.47 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | C02 | 3.0 degrees | Standard Deviation 9.43 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | T03 | 1.7 degrees | Standard Deviation 3.79 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | C03 | 4.0 degrees | Standard Deviation 16.42 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | T04 | 4.2 degrees | Standard Deviation 13.9 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | C04 | 1.3 degrees | Standard Deviation 2.6 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | T05 | 3.3 degrees | Standard Deviation 9.32 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | C05 | 5.3 degrees | Standard Deviation 9.37 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | T06 | 2.8 degrees | Standard Deviation 12.78 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | C06 | 5.0 degrees | Standard Deviation 16.56 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | T07 | 5.7 degrees | Standard Deviation 11.58 |
| All Participants Received Kalifilcon LD213001 ContactLenses and Ultra for Astigmatism Contact Lenses | Mean Absolute Primary Gaze Orientation at 3 Minutes for the Lenses Inserted at 90 Degrees | T08 | 3.5 degrees | Standard Deviation 7.09 |