Refractive Ametropia
Conditions
Brief summary
To evaluate and compare the performance of a new contact lens to a marketed contact lens.
Interventions
DEVICEetafilcon A with print and PVP for dark eyes (EAPVPDE)
A daily disposable contact lens
DEVICEetafilcon A control lens (EADE)
A marketed 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
* The subject must be a healthy adult at least 18 years of age and no more than 34 years of age. * The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes). * The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate. * The subject must have no known ocular or systemic allergies that might interfere with contact lens wear. * The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear. * The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D. * Any cylinder power must be:\<=0.75D. * The subject must have visual acuity best correctable to 20/25 or better for each eye. * The subject must have normal eyes (no ocular medications or ocular infection of any type). * The subject must read and sign the Statement of Informed Consent. * The subject 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 (color blindness) - 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 is an employee or family member of the clinical study site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire | After 7 to 9 days of lens wear | The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120. |
| Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire | After 7 to 9 days of lens wear | The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. |
| Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire | After 7 to 9 days of lens wear | The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. |
Countries
United States
Participant flow
Pre-assignment details
Of those 103 enrolled subjects, 3 subjects did not receive the study article.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All enrolled subjects who received study lenses. | 100 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 25.07 years STANDARD_DEVIATION 4.879 |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 100 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 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire
The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: After 7 to 9 days of lens wear
Population: Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| EAPVPDE | Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire | 53.61 units on a scale | Standard Error 2.201 |
| EADE | Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire | 48.91 units on a scale | Standard Error 2.197 |
Comparison: The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Lens Comfort at 7-9 days of follow-up.95% CI: [-0.79, 10.19]Mixed Models Analysis
Primary
Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire
The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: After 7 to 9 days of lens wear
Population: Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| EAPVPDE | Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire | 61.21 units on a scale | Standard Error 1.847 |
| EADE | Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire | 51.77 units on a scale | Standard Error 1.842 |
Comparison: Ho: The test lens is non-inferior to the active comparator lens for Handling at 7-9 days follow-up.95% CI: [5.81, 13.07]Mixed Models Analysis
Primary
Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire
The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.
Time frame: After 7 to 9 days of lens wear
Population: Analysis was conducted on subjects who successfully complete the study without a protocol deviation affecting at least one primary endpoint.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| EAPVPDE | Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire | 54.06 units on a scale | Standard Error 2.538 |
| EADE | Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire | 53.06 units on a scale | Standard Error 2.537 |
Comparison: The alternative hypothesis is that etafilcon A with PVP lenses is non-inferior to etafilcon A control lenses for the Overall Quality of Lens Vision at 7-9 days of follow-up.95% CI: [-3.2, 5.2]Mixed Models Analysis