Myopia
Conditions
Keywords
Contact lenses
Brief summary
The purpose of this study is to assess the clinical performance of an investigational contact lens 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 60 days (30 days for each 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
Key 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; * Current wearer of spherical weekly/monthly soft contact lenses in both eyes with at least 3 months wearing time of 5 days per week and 10 hours per day; * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Current or prior Biofinity contact lens wearer in the past 3 months; * Monovision contact lens wearer; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Distance Visual Acuity (logMAR) With Study Lenses | Day 1, Day 30 after 6-8 hours of wear, each product | Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned. |
Countries
United States
Participant flow
Recruitment details
Subjects were enrolled at 5 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all subjects/eyes (66/132) exposed to any study lenses evaluated in this study as treated (Safety Analysis Set)
Participants by arm
| Arm | Count |
|---|---|
| LID018869, Then Biofinity Lehfilcon A contact lenses worn first, followed by comfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection. | 31 |
| Biofinity, Then LID018869 Comfilcon A contact lenses worn first, followed by lehfilcon A contact lenses, as randomized. Each product was worn in both eyes during waking hours only for at least 5 days per week over a 30-day period. CLEAR CARE was used for nightly cleaning and disinfection. | 35 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Wear Period (30 Days ± 2 Days) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | LID018869, Then Biofinity | Total | Biofinity, Then LID018869 |
|---|---|---|---|
| Age, Continuous | 32.6 years STANDARD_DEVIATION 8 | 33.2 years STANDARD_DEVIATION 8.3 | 33.7 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 66 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 30 Participants | 64 Participants | 34 Participants |
| Region of Enrollment United States | 31 participants | 66 participants | 35 participants |
| Sex: Female, Male Female | 24 Participants | 52 Participants | 28 Participants |
| Sex: Female, Male Male | 7 Participants | 14 Participants | 7 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 / 66 | 0 / 132 | 0 / 66 | 0 / 130 | 0 / 65 |
| other Total, other adverse events | 0 / 66 | 0 / 132 | 0 / 66 | 0 / 130 | 0 / 65 |
| serious Total, serious adverse events | 0 / 66 | 0 / 132 | 0 / 66 | 0 / 130 | 0 / 65 |
Outcome results
Primary
Mean Distance Visual Acuity (logMAR) With Study Lenses
Visual acuity (VA) was collected for each eye individually with study lenses in place at a distance of 4 meters using a letter chart. VA was measured in logarithm minimum angle of resolution (logMAR). On Day 30, VA was assessed after 6-8 hours of wear. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. No formal hypothesis testing was planned.
Time frame: Day 1, Day 30 after 6-8 hours of wear, each product
Population: Full Analysis Set: All randomized subjects who are exposed to any study lenses evaluated in this study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LID018869 | Mean Distance Visual Acuity (logMAR) With Study Lenses | Day 1 | -0.11 logMAR | Standard Deviation 0.08 |
| LID018869 | Mean Distance Visual Acuity (logMAR) With Study Lenses | Day 30, after 6-8 hours of wear | -0.12 logMAR | Standard Deviation 0.07 |
| Biofinity | Mean Distance Visual Acuity (logMAR) With Study Lenses | Day 1 | -0.13 logMAR | Standard Deviation 0.08 |
| Biofinity | Mean Distance Visual Acuity (logMAR) With Study Lenses | Day 30, after 6-8 hours of wear | -0.13 logMAR | Standard Deviation 0.08 |