Refractive Errors
Conditions
Brief summary
The purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear.
Interventions
DEVICELID014341 contact lenses
Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating
Silicone hydrogel contact lenses
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to understand and sign an informed consent form approved by an Institutional review board (IRB); * Successful wear of spherical monthly replacement soft 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; * Willing to stop wearing habitual contact lenses for the duration of study participation.
Exclusion criteria
* Any conditions or use of medications that could contraindicate contact lens wear; * History of or plan to have refractive surgery in either eye; * Irregular cornea in either eye; * Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study; * Current or history of intolerance, hypersensitivity or allergy to any component of the study products; * Wearing habitual contact lenses 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 and artificial tear or rewetting drops requiring instillation during contact lens wear; * Habitual Biofinity contact lens wearers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity (VA) | Day 30 | VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 4 study centers located in the US.
Pre-assignment details
Of the 88 enrolled, 2 subjects exited as screen failures prior to randomization. This reporting group includes all randomized subjects (86).
Participants by arm
| Arm | Count |
|---|---|
| LID014341 LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis | 58 |
| LID014341 LID014341 contact lenses were worn bilaterally (in both eyes) for 30 days on a daily wear basis | 116 |
| Biofinity Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis | 28 |
| Biofinity Comfilcon A contact lenses were worn bilaterally for 30 days on a daily wear basis | 56 |
| Total | 258 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 1 | 0 |
Baseline characteristics
| Characteristic | Biofinity | Total | LID014341 |
|---|---|---|---|
| Age, Continuous | 40.7 years STANDARD_DEVIATION 12.9 | 39.6 years STANDARD_DEVIATION 12 | 39.0 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 82 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 77 Participants | 52 Participants |
| Sex: Female, Male Female | 20 Participants | 58 Participants | 38 Participants |
| Sex: Female, Male Male | 8 Participants | 28 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 28 |
| other Total, other adverse events | 0 / 58 | 0 / 28 |
| serious Total, serious adverse events | 0 / 58 | 0 / 28 |
Outcome results
Primary
Distance Visual Acuity (VA)
VA was tested monocularly (each eye individually) without visual correction under photopic (well-lit) conditions. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. Both eyes contributed to the analysis. No formal statistical hypothesis testing was planned.
Time frame: Day 30
Population: Safety Analysis Set. Overall number of units analyzed is the number of eyes with non-missing response.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LID014341 | Distance Visual Acuity (VA) | -0.09 logMAR | Standard Deviation 0.07 |
| Biofinity | Distance Visual Acuity (VA) | -0.09 logMAR | Standard Deviation 0.07 |