Myopia
Conditions
Brief summary
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).
Detailed description
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.
Interventions
DEVICETest Contact Lens
Daily disposable contact lens
DEVICENelfilcon A
Focus Dailies All Day Comfort contact lens (nelfilcon A)
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The contact lenses coding will be masked to both the investigator and subject. If standard labeling does not sufficiently mask the study material then over-labeling will be performed.
Intervention model description
This will be a double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Is at least 18 years of age and has full legal capacity to volunteer. * Is no greater than 55 years of age. * Has read and understood the information consent letter. * Is willing and able to follow instructions and maintain the appointment schedule. * Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study. * Has spectacle cylinder ≤1.00D in both eyes. * Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes. * Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye. * Wears CLs in both eyes (monvision acceptable, but not monofit) * Has clear corneas and no active ocular disease. * Has not worn lenses for at least 12 hours before the examination. * Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week
Exclusion criteria
* Has never worn contact lenses before. * Has any systemic disease affecting ocular health. * Is using any systemic or topical medications that will affect ocular health. * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * Is aphakic. * Has strabismus/amblyopia. * Has undergone corneal refractive surgery. * Is pregnant, lactating or planning a pregnancy. * Is participating in any concurrent clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit Acceptance | Baseline | Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Per randomized schedule, subject will wear either a pair of the test lens or control lens for one week and then cross-over to the other pair for 1 week.
Test Contact Lens: Daily disposable contact lens
Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A) | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 45 Participants | — |
| Age, Continuous | 26 years STANDARD_DEVIATION 8 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 45 participants | — |
| Sex: Female, Male Female | 32 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lens | Lens Fit Acceptance | 2.6 units on a scale | Standard Deviation 0.6 |
| Nelfilcon A Lens (Control) | Lens Fit Acceptance | 3.1 units on a scale | Standard Deviation 0.3 |
Primary
Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Time frame: 1-Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Contact Lens | Lens Fit Acceptance | 2.6 units on a scale | Standard Deviation 0.6 |
| Nelfilcon A Lens (Control) | Lens Fit Acceptance | 3.0 units on a scale | Standard Deviation 0.4 |