Refractive Errors
Conditions
Keywords
Contact lenses
Brief summary
The purpose of this study is to compare the clinical performance of LID018869 soft contact with ACUVUE® OASYS with HYDRACLEAR® PLUS (AOHP) soft contact lenses over 30 days of daily wear.
Detailed description
Subjects will be expected to attend 6 visits. Subjects will be expected to wear their study contact lenses every day for at least 10 hours per day over a 30-day period for each study lens type. The total duration of a subject's participation in the study will be approximately 65 days.
Interventions
Commercially available, silicone hydrogel, spherical contact lenses used as indicated
Commercially available, silicone hydrogel, spherical contact lenses used as indicated
DEVICECLEAR CARE
Hydrogen peroxide-based contact lens 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: * Current wearer of a commercial spherical weekly/monthly soft contact lenses with at least 3 months of wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day. * Manifest cylinder less than or equal to 0.75 diopter in each eye. * Best corrected distance visual acuity better than or equal to 20/25 Snellen in each eye. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Monovision or multifocal lens wearer. * Habitual senofilcon contact lens wearer (for example, Acuvue Oasys, Acuvue Vita) or commercially available lehfilcon A contact lens wearer (TOTAL30). * Routinely sleeps in habitual contact lenses. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30 | Day 30, each study lens type | 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). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 10 investigative sites located in the United States.
Pre-assignment details
Of the 166 enrolled, 3 subjects were exited from the study prior to randomization as screen failures, and 1 randomized subject was discontinued prior to exposure to the study lenses. This reporting group includes all subjects exposed to the study lenses, as treated (162).
Participants by arm
| Arm | Count |
|---|---|
| LID018869, Then AOHP Lehfilcon A contact lenses worn in Period 1, followed by senofilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE was used for daily contact lens cleaning and disinfection. | 82 |
| AOHP, Then LID018869 Senofilcon A contact lenses worn in Period 1, followed by lehfilcon A contact lenses worn in Period 2, as randomized. Each product was worn in both eyes during waking hours only for at least 10 hours per day for 30 days. CLEAR CARE was used for daily contact lens cleaning and disinfection. | 80 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1, 30 Days | Lost to Follow-up | 1 | 1 |
| Period 1, 30 Days | Withdrawal by Subject | 1 | 0 |
| Period 2, 30 Days | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | LID018869, Then AOHP | AOHP, Then LID018869 | Total |
|---|---|---|---|
| Age, Continuous | 32.4 years STANDARD_DEVIATION 8.2 | 33.1 years STANDARD_DEVIATION 8.5 | 32.8 years STANDARD_DEVIATION 8.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 11 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 70 Participants | 69 Participants | 139 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 | 20 Participants | 18 Participants | 38 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Multi-racial | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 56 Participants | 55 Participants | 111 Participants |
| Sex: Female, Male Female | 45 Participants | 49 Participants | 94 Participants |
| Sex: Female, Male Male | 37 Participants | 31 Participants | 68 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 / 162 | 0 / 322 | 0 / 161 | 0 / 320 | 0 / 160 |
| other Total, other adverse events | 0 / 162 | 0 / 322 | 0 / 161 | 0 / 320 | 0 / 160 |
| serious Total, serious adverse events | 0 / 162 | 0 / 322 | 0 / 161 | 0 / 320 | 0 / 160 |
Outcome results
Primary
Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30
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). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
Time frame: Day 30, each study lens type
Population: Full Analysis Set: All randomized subjects who were exposed to any study lenses evaluated in this clinical study with data at Day 30.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| LID018869 | Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30 | -0.07 logMAR | Standard Error 0.006 |
| AOHP | Least Squares Mean Distance Visual Acuity With Study Lenses at Day 30 | -0.07 logMAR | Standard Error 0.006 |