Myopia
Conditions
Brief summary
The purpose of this study was to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers over a one-month period of lens wear.
Detailed description
This was a prospective, multiple day, double-masked (investigator and subject), randomized, bilateral re-fit parallel arm study comparing a Test Lens against an appropriate Control Lens. Participants were randomized to wear the Test or Control lens for 30±2 days.
Interventions
DEVICEControl Lenses (comfilcon A with current process)
Daily wear lenses for 30±2 days
DEVICETest Lenses (comfilcon A with novel process)
Daily wear lenses for 30±2 days
Sponsors
CooperVision International Limited (CVIL)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have had a self-reported oculo-visual examination in the last year. * Are at least 18 years of age and has full legal capacity to give their informed consent. * Have read and understood the informed consent letter. * Are willing and able to follow instructions and maintain the appointment schedule. * Have a contact lens spherical prescription between -0.50 D to -6.00 D (inclusive) * Are correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. * Have spectacle cylinder of ≤ 0.75 D in both eyes. * Is a habitual comfilcon A wearer and worn a comfilcon A lens for at least one month (minimum of 8 hours a day, 5 days per week) * Currently employ the use of a peroxide or multipurpose solution cleaning and disinfecting regimen in one of the following brand names: * Bausch and Lomb BioTrue Multi-Purpose Solution * Bausch and Lomb BioTrue Hydration Plus Multi-Purpose Solution * Bausch and Lomb ReNu Advanced Formulation Multi-Purpose Solution * Alcon Opti-Free Puremoist with Hydraglyde Multi-Purpose Solution * Alcon Opti-Free Replenish Multi-Purpose Solution * Alcon Clear Care Plus Hydrogen Peroxide Solution * Acuvue RevitaLens Multi-Purpose Solution * Have clear corneas and no active ocular disease. * Have not worn habitual lenses for at least 12 hours before the baseline/screening examination * Are willing to wear the study contact lenses for at least 8 hours per day, 5 days per week
Exclusion criteria
* Have never worn contact lenses before. * Are currently wearing daily disposable contact lenses. * Have any systemic disease affecting ocular health. * Are using any systemic or topical medications that will affect ocular health. * Have any ocular pathology or abnormality that would affect the wearing of contact lenses. * Have any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * Are aphakic. * Have undergone corneal refractive surgery. * Are participating in any other type of eye related clinical or research study. * Require a change in lens power from more than 1 diopter as dictated by over-refraction with their habitual lens prescription.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 4 weeks | Monocular distance logMAR visual acuity at distance 4 meters under high illumination, high contrast conditions was measured at the 4 week timepoint of lens wear. |
Countries
United States
Participant flow
Pre-assignment details
Three participants did not meet the inclusion criteria and were excluded from the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Control Lenses Participants that received the Control Lens | 25 |
| Test Lenses Participants that received the Test Lens | 47 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Control Lenses | Test Lenses | Total |
|---|---|---|---|
| Age, Continuous | 30.6 years STANDARD_DEVIATION 11 | 29.0 years STANDARD_DEVIATION 8.5 | 29.5 years STANDARD_DEVIATION 9.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 21 Participants | 29 Participants | 50 Participants |
| Sex: Female, Male Male | 4 Participants | 18 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 48 |
| other Total, other adverse events | 0 / 26 | 1 / 48 |
| serious Total, serious adverse events | 0 / 26 | 0 / 48 |
Outcome results
Primary
Visual Acuity
Monocular distance logMAR visual acuity at distance 4 meters under high illumination, high contrast conditions was measured at the 4 week timepoint of lens wear.
Time frame: 4 weeks
Population: Analysis population includes all participants that were eligible (inclusion/exclusion criteria) and completed all study visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Lenses | Visual Acuity | -0.07 logMAR | Standard Deviation 0.08 |
| Test Lenses | Visual Acuity | -0.13 logMAR | Standard Deviation 0.08 |