Visual Acuity
Conditions
Brief summary
This is a single-site, 8-visit, double-masked, cross-over study involving three marketed products as study lenses. Participants will be randomly assigned each lens type, which will be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a minimum washout period of 3 days before entering the study and undergo a minimum 7 day washout period between dispensing each lens type.
Interventions
DEVICELens 1 (etafilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
DEVICELens 2 (nelfilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
DEVICELens 3 (nesofilcon A)
Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form; * The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol; * The subject must be willing and able to follow instructions and maintain the appointment schedule; * The subject must be between the age of 18 and 40 years (inclusive); * The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -6.00 D in each eye (inclusive); * The subject's refractive cylinder must not exceed -1.25 Diopters of Cylinder (DC) in each eye after vertexing to the corneal plane; * The subject must have best corrected visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye; * The subject must be a current wearer of spherical, soft contact lenses (no toric, bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment; * The subject must own a wearable pair of spectacles and wear them the day of the initial visit; * The subject must be an existing wearer of spherical, soft contact lenses in both eyes; * The subject must have normal eyes (i.e., no ocular medications or infections of any type); * The subject must be willing to wear the study lenses for a minimum eight hours per day.
Exclusion criteria
* Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion); * Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion); * Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued); * Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease; * Any active ocular infection; * Is using any topical medications (excluding artificial tears (ATS)) up to two weeks prior to the screening visit; * Any participants whose habitual contact lenses are used as an extended wear regimen; * Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry; * Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.); * Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear; or clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear; * Any known hypersensitivity or allergic reaction to the study products; * Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment; * Employee or family member of the Centre for Contact Lens Research (e.g., Investigator, Coordinator, Technician).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Comfort | 2- Week Follow-up | Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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
Canada
Participant flow
Pre-assignment details
A total of 78 subjects were enrolled in this study. Of the enrolled subjects 74 subjects were dispensed at least 1 study lens and 4 subjects did not meet the eligbility criteria. Of the dispensed subjects 72 completed the study and 2 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Dispensed Subjects All subjects that were dispensed at least 1 study lens. | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period 2 | Adverse Event | 0 | 0 | 1 | 0 | 0 | 0 |
| Period 3 | Unstatisfactory Lens fitting | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Dispensed Subjects |
|---|---|
| Age, Continuous | 24.3 Years STANDARD_DEVIATION 5.71 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Asian | 25 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized White | 45 Participants |
| Region of Enrollment North America | 74 Participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 74 | 0 / 74 | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 | 0 / 74 | 0 / 74 |
Outcome results
Primary
Overall Comfort
Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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: 2- Week Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Overall Comfort | 58.74 Units on a scale | Standard Deviation 25.35 |
| Nelfilcon A | Overall Comfort | 48.14 Units on a scale | Standard Deviation 25.166 |
| Nesofilcon A | Overall Comfort | 57.32 Units on a scale | Standard Deviation 25.84 |