Myopia
Conditions
Keywords
Contact lenses
Brief summary
The purpose of this study is to compare the clinical performance of TOTAL30 contact lenses with Biofinity contact lenses over 30 days of daily wear.
Detailed description
Subjects will wear two products and be expected to attend 4 office visits. The individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.
Interventions
Investigational silicone hydrogel contact lenses
Commercially available silicone hydrogel contact lenses
DEVICECLEAR CARE
Hydrogen peroxide-based cleaning and disinfecting solution
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 No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand and sign an approved Informed Consent form; * Willing and able to attend all scheduled study visits as required by the protocol; * Currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day; * Manifest cylinder less than or equal to 0.75 diopter (D) in each eye; * Willing to stop wearing habitual contact lenses for the duration of study participation. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Any eye condition that contraindicates contact lens wear, as determined by the Investigator; * Any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the Investigator; * Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study; * Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; * Current or prior Biofinity contact lens wear in the past 3 months prior to consent. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Distance VA (logMAR) With Study Lenses | Day 30, each study product | Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity. |
Countries
United States
Participant flow
Recruitment details
This study was conducted at 14 investigative sites located in the United States.
Pre-assignment details
Of the 257 enrolled, 8 subjects were exited prior to randomization as screen failures. This reporting group includes all subjects exposed to the study lenses, as treated (249). Note: One subject randomized to TOTAL30, then Biofinity was exposed to the incorrect study lenses in the sequence (Biofinity, then TOTAL30).
Participants by arm
| Arm | Count |
|---|---|
| TOTAL30, Then Biofinity Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection. | 123 |
| Biofinity, Then TOTAL30 Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each study product was worn bilaterally (in both eyes) for approximately 30 days for at least 10 hours per day during waking hours only. CLEAR CARE was used for daily cleaning and disinfection. | 126 |
| Total | 249 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (Approximately 30 Days) | Adverse Event | 2 | 0 |
| Period 1 (Approximately 30 Days) | Lost to Follow-up | 0 | 1 |
| Period 1 (Approximately 30 Days) | Withdrawal by Subject | 1 | 2 |
| Period 2 (Approximately 30 Days) | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Biofinity, Then TOTAL30 | Total | TOTAL30, Then Biofinity |
|---|---|---|---|
| Age, Continuous | 33.1 years STANDARD_DEVIATION 8.7 | 32.6 years STANDARD_DEVIATION 8.2 | 32.1 years STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 17 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 118 Participants | 232 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 41 Participants | 78 Participants | 37 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 9 Participants | 4 Participants |
| Race/Ethnicity, Customized Multi-racial | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 79 Participants | 159 Participants | 80 Participants |
| Region of Enrollment United States | 126 participants | 249 participants | 123 participants |
| Sex: Female, Male Female | 87 Participants | 178 Participants | 91 Participants |
| Sex: Female, Male Male | 39 Participants | 71 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 249 | 0 / 490 | 0 / 245 | 0 / 492 | 0 / 246 |
| other Total, other adverse events | 0 / 249 | 0 / 490 | 0 / 245 | 0 / 492 | 0 / 246 |
| serious Total, serious adverse events | 0 / 249 | 0 / 490 | 2 / 245 | 0 / 492 | 0 / 246 |
Outcome results
Primary
Least Squares Mean Distance VA (logMAR) With Study Lenses
Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Time frame: Day 30, each study product
Population: All subjects exposed to any study lenses evaluated in this study, as randomized, with non-missing response (eye)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| TOTAL30 | Least Squares Mean Distance VA (logMAR) With Study Lenses | -0.07 logMAR | Standard Error 0.005 |
| Biofinity | Least Squares Mean Distance VA (logMAR) With Study Lenses | -0.08 logMAR | Standard Error 0.005 |