Visual Acuity
Conditions
Brief summary
This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treament, 2-sequence, 3-period crossover study to evalulate overall vision and comfort..
Interventions
DEVICEsoft contact lens in senofilcon A (C3) with HEVL-blocking chromophore
TEST Lens
CONTROL Lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
Potential subjects must satisfy of all the following criteria to be enrolled in the study. 1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. 2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. Be between 18 and 39 years of age (inclusive) at the time of screening. 4. By self-report, habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks. 5. Possess a wearable pair of spectacles that provide correction for distance vision. 6. In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study: 1. Sphere powers (DS) -1.50 through -4.00 in 0.25 steps 2. Cylinder powers (DC) -0.75 and -1.25 3. Axes (degrees) 170, 180, 10, 80, 90, 100 7. Have best corrected monocular distance visual acuity of 20/30 or better in each eye.
Exclusion criteria
Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Be currently pregnant or lactating. 2. Be diabetic. 3. Be currently using any ocular medications or have an ocular infection of any type. 4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. 5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. 6. Be currently wearing monovision or multifocal contact lenses. 7. Be currently wearing lenses in an extended wear modality. 8. Have a history of strabismus or amblyopia. 9. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site. 10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CLUE Comfort Score | 1-Week Follow-up | Subjective comfort was assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (Comfort, Vision, Handling, and Packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution where scores range from 0 to 120 with a population average score of 60 (SD 20). Higher CLUE scores indicate a more favorable/positive response. The average CLUE comfort score was report for each lens type. |
Countries
United States
Participant flow
Recruitment details
A total of 126 subjects were enrolled in this study. Of those enrolled, all 126 subjects were dispensed at least one study lens. Of those dispensed, 119 subjects completed the study while 7 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects dispensed at least one study lens. | 126 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 | Subject out of visit window | 1 | 1 |
| Period 2 | Adverse Event | 1 | 0 |
| Period 2 | Covid-19 Related | 1 | 0 |
| Period 2 | Subject out of visit window | 1 | 1 |
| Period 3 | Subject out of visit window | 1 | 0 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 29.4 Years STANDARD_DEVIATION 5.86 |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African American | 11 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 111 Participants |
| Region of Enrollment United States | 126 Participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 125 | 0 / 125 |
| other Total, other adverse events | 0 / 125 | 0 / 125 |
| serious Total, serious adverse events | 0 / 125 | 0 / 125 |
Outcome results
Primary
CLUE Comfort Score
Subjective comfort was assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (Comfort, Vision, Handling, and Packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution where scores range from 0 to 120 with a population average score of 60 (SD 20). Higher CLUE scores indicate a more favorable/positive response. The average CLUE comfort score was report for each lens type.
Time frame: 1-Week Follow-up
Population: All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hard lock.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test [Senofilcon A (C3) HEV Chromophore] | CLUE Comfort Score | 63.50 Units on a scale | Standard Deviation 19.581 |
| Control [Senofilcon A (C3)] | CLUE Comfort Score | 65.28 Units on a scale | Standard Deviation 20.915 |
95% CI: [-6.92, 1.07]Generalized Linear Mixed Model