Contact Lens Wearer
Conditions
Brief summary
The objective of this 2 hour study is to evaluate the clinical performance of samfilcon A lenses with an alternate packaging solution (EPG01) compared to commercially available B+L Ultra lenses.
Interventions
DEVICEsamfilcon A Lenses with EPG01 Packaging Solution
samfilcon A Lenses with EPG01 Packaging Solution
DEVICECommercially Available B+L Ultra Lenses
Commercially Available B+L Ultra Lenses
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Normalized logMAR Visual Acuity | Assessed at 2-hour post-baseline | Normalized logMAR visual acuity is the change in visual acuity (how well you can see) from baseline (spectacle). Normalized visual acuity is calculated by subtracting the logMAR visual acuity with a contact lens from the baseline (refraction without a contact lens). Each letter on the logMAR visual acuity chart has a value of 0.02. |
Countries
United States
Participant flow
Pre-assignment details
This is a contralateral study. 30 subjects were enrolled and were dispensed lenses based on a randomization schedule.
Participants by arm
| Arm | Count |
|---|---|
| Samfilcon A Lenses With EPG01 Packaging Solution and Commercially Available B+L Ultra Lenses. Participants were implanted with both samfilcon A Lenses with EPG01 Packaging Solution and commercially available B+L Ultra lenses. | 30 |
| Samfilcon A Lenses With EPG01 Packaging Solution and Commercially Available B+L Ultra Lenses. Participants were implanted with both samfilcon A Lenses with EPG01 Packaging Solution and commercially available B+L Ultra lenses. | 60 |
| Total | 90 |
Baseline characteristics
| Characteristic | Samfilcon A Lenses With EPG01 Packaging Solution and Commercially Available B+L Ultra Lenses. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 40.7 Years STANDARD_DEVIATION 12.62 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 18 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
Normalized logMAR Visual Acuity
Normalized logMAR visual acuity is the change in visual acuity (how well you can see) from baseline (spectacle). Normalized visual acuity is calculated by subtracting the logMAR visual acuity with a contact lens from the baseline (refraction without a contact lens). Each letter on the logMAR visual acuity chart has a value of 0.02.
Time frame: Assessed at 2-hour post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Samfilcon A Lenses With EPG01 Packaging Solution | Normalized logMAR Visual Acuity | INS visit | 0.005 LogMAR units | Standard Deviation 0.0577 |
| Samfilcon A Lenses With EPG01 Packaging Solution | Normalized logMAR Visual Acuity | FUP visit | -0.001 LogMAR units | Standard Deviation 0.0663 |
| Commercially Available B+L Ultra Lenses | Normalized logMAR Visual Acuity | INS visit | 0.003 LogMAR units | Standard Deviation 0.0633 |
| Commercially Available B+L Ultra Lenses | Normalized logMAR Visual Acuity | FUP visit | 0.008 LogMAR units | Standard Deviation 0.0632 |