Astigmatism
Conditions
Brief summary
Comparing Test Lens for Astigmatism Soft Contact Lens (Test) to 1-Day Control for Astigmatism contact lenses (Control).
Detailed description
This is a multicenter, randomized 1:1, parallel-group, bilateral, Investigator-masked study at 13 investigative sites in the United States (US) in a population including Chinese subjects (maternal and paternal grandparents born in China)
Interventions
DEVICEControl
Contact Lens
DEVICETest
Soft Contact Lens
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Subjects will be dispensed product according to the treatment arm corresponding to their randomization and will be unmasked. The Investigator will be masked.
Intervention model description
Investigator/Sponsor masked, randomized, open-label, parallel-group, multicenter study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subject must be of legal age (at least 18 or as defined by state law) on the date the ICF is signed and have the capacity to provide voluntary informed consent. * Subject must be able to read, understand and provide written informed consent on the IRB approved ICF and provide authorization as appropriate for local privacy regulations. * Subject must have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than Grade 1 and/or presence of infiltrates) and have clear central 6 mm corneas. * Subject must be an adapted wearer of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
Exclusion criteria
* Subject has worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months. * Subject has systemic disease affecting ocular health. * Subject is using any systemic or topical medications that will affect ocular physiology or lens performance. * Subject has an active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications. * Subject has any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better | Evaluated at the 1 week follow up visit | The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biotrue Biotrue ONEday for Astigmatism Soft Contact Lens® | 123 |
| Acuvue 1-Day Acuvue Moist for Astigmatism Contact Lens | 119 |
| Total | 242 |
Baseline characteristics
| Characteristic | Acuvue | Total | Biotrue |
|---|---|---|---|
| Age, Continuous | 32.9 years | 33.3 years | 33.7 years |
| Ancestry Chinese | 41 Participants | 86 Participants | 45 Participants |
| Ancestry Non-Chinese | 78 Participants | 156 Participants | 78 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 59 Participants | 119 Participants | 60 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 24 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 91 Participants | 42 Participants |
| Sex: Female, Male Female | 72 Participants | 150 Participants | 78 Participants |
| Sex: Female, Male Male | 47 Participants | 92 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 123 | 0 / 119 |
| other Total, other adverse events | 0 / 123 | 0 / 119 |
| serious Total, serious adverse events | 0 / 123 | 0 / 119 |
Outcome results
Primary
Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better
The proportion of participants achieving a contact lens corrected distance logMAR VA of 0.04 or better in both eyes
Time frame: Evaluated at the 1 week follow up visit
Population: The Per Protocol (PP) Population included all randomized participants without major protocol deviations who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Biotrue | Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better | 105 Participants |
| Acuvue | Proportion of Participants Achieving a Contact Lens Corrected Distance logMAR VA of 0.04 or Better | 92 Participants |