Refractive Errors
Conditions
Brief summary
The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.
Interventions
DEVICEComfilcon A with Digital Zone Optics™ contact lenses
Silicone hydrogel spherical contact lenses with Digital Zone Optics™
Silicone hydrogel spherical contact lenses
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Able to understand and sign an approved informed consent form (ICF); * Successful wear of BIOFINITY® (spherical) (or private label) contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months; * Best-corrected visual acuity (BCVA) 20/25 or better in each eye; * Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed); * Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear; * Any use of systemic or ocular medications for which contact lens wear could be contraindicated; * Refractive, ocular, or intraocular surgery, as specified in the protocol; * Current or history of eye injury or disorders, as specified in the protocol; * Current or history of intolerance, hypersensitivity or allergy to any component of the study products; * Habitual contact lens wear in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment; * Use of topical ocular medications that would require instillation during contact lens wear; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Rating of Overall Vision | Day 7, each product | Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Over-refraction | Day 1 (Dispense), each product | Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from one study site located in the US.
Pre-assignment details
All 15 enrolled subjects were randomized and exposed to investigational product. This reporting group includes all randomized and treated subjects (15).
Participants by arm
| Arm | Count |
|---|---|
| Overall Comfilcon A with Digital Zone Optics™ contact lenses and comfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 28.3 years STANDARD_DEVIATION 3.6 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Multi-Racial | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 14 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Subjective Rating of Overall Vision
Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.
Time frame: Day 7, each product
Population: Safety Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOFINITY ENERGYS | Subjective Rating of Overall Vision | 8.6 units on a scale | Standard Deviation 1.2 |
| BIOFINITY | Subjective Rating of Overall Vision | 8.6 units on a scale | Standard Deviation 1.1 |
Secondary
Over-refraction
Over-refraction (amount of additional correction needed to improve visual acuity (VA)) was collected for each eye and measured in diopters (D). Inferential testing was not planned for this endpoint.
Time frame: Day 1 (Dispense), each product
Population: Safety Analysis Set
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| BIOFINITY ENERGYS | Over-refraction | -0.25D | 3 Eyes |
| BIOFINITY ENERGYS | Over-refraction | 0.00D | 26 Eyes |
| BIOFINITY ENERGYS | Over-refraction | +0.25D | 1 Eyes |
| BIOFINITY | Over-refraction | -0.25D | 0 Eyes |
| BIOFINITY | Over-refraction | 0.00D | 24 Eyes |
| BIOFINITY | Over-refraction | +0.25D | 6 Eyes |