Refractive Ametropia
Conditions
Brief summary
This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.
Interventions
DEVICEetafilcon A control lens (1DM)
A marketed daily disposable contact lens
DEVICEetafilcon A with print and PVP for light eyes (EALE)
A daily disposable contact lens
DEVICEetafilcon A with print and PVP for dark eyes (EADE)
A daily disposable contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
No
Inclusion criteria
* Healthy, female adult, at least 18 years of age, and no more than 34 years of age * The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes * Must have rated the Concept Statement positively (i.e., a rating of 4 or 5). * Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D) * Any cylinder power must be: \<=0.75D * Visual acuity must be best correctable to 20/25 or better for each eye * Must have normal eyes (no ocular medications or ocular infection of any type) * Must read and sign the Statement of Informed Consent * Must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion criteria
* Ocular or systemic allergies or disease which might interfere with contact lens wear * Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear * Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear * Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear * Any ocular infection * Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear * Any color deficiencies (colorblindness) - to the best of the subject's knowledge * Pregnancy or lactation * Diabetes * Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV) * Habitual contact lens type is toric, multifocal, or is worn as extended wear. * Subject presents with one dark iris color and one light iris color. * Subject has heterochromia iridis (a difference in color between parts of one iris). * The subject must not be an employee or family member of the clinical study site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Visual Acuity | Dispensing | Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a\*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score. |
| Lens Fit Acceptance | Dispensing | The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no). |
| Corneal Staining of Grade 3 or 4 | After 7-9 days of lens wear | Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade \>= 3 were reported. |
Countries
United States
Participant flow
Pre-assignment details
Of those 275 enrolled subjects, 267 subjects were randomized and received the study article in the study. Two subjects were discontinued between the first and second periods.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All randomized subjects who worn at least one pair of study lenses. | 267 |
| Total | 267 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period 1 | Lens Discomfort | 0 | 1 | 0 | 0 |
| Period 1 | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Period 1 | Non-Compliance to Protocol | 0 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 267 Participants |
| Age, Continuous | 24.94 years STANDARD_DEVIATION 4.654 |
| Sex: Female, Male Female | 267 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 267 | 0 / 267 |
| serious Total, serious adverse events | 0 / 267 | 0 / 267 |
Outcome results
Primary
Corneal Staining of Grade 3 or 4
Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade \>= 3 were reported.
Time frame: After 7-9 days of lens wear
Population: Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EADE/EALE | Corneal Staining of Grade 3 or 4 | 0 % of Eyes |
| 1-DM | Corneal Staining of Grade 3 or 4 | 0 % of Eyes |
Primary
Lens Fit Acceptance
The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).
Time frame: Dispensing
Population: Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EADE/EALE | Lens Fit Acceptance | 100 % of Eyes |
| 1-DM | Lens Fit Acceptance | 100 % of Eyes |
Primary
Monocular Visual Acuity
Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a\*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.
Time frame: Dispensing
Population: Analysis was conducted on all randomized subjects who wore at least one pair of study lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EADE/EALE | Monocular Visual Acuity | -0.044 LogMAR score | Standard Deviation 0.0618 |
| 1-DM | Monocular Visual Acuity | -0.060 LogMAR score | Standard Deviation 0.0589 |
Comparison: The alternative hypothesis is the monocular distance Snellen VA (LogMAR scale) of etafilcon A with embedded print and PVP for dark/light eyes is non-inferior to that of etafilcon A control lenses.95% CI: [0.004, 0.017]Mixed Models Analysis