Visual Disorders
Conditions
Brief summary
This is a multi-site, dispensing, 4-visit, 2-arm parallel group, randomized, double-masked clinical trial using a Vistakon investigational contact lens (test) and a marketed monthly replacement contact lens (control). Each subject will be assigned randomly to either the test or control lens to evaluate the long term safety and efficacy of the investigational contact lens compared to the marketed contact lens over a period of six months of lens wear.
Interventions
DEVICEsenofilcon C
DEVICEcomfilcon A
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 at least 18 years of age. * The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye. * The subject's refractive cylinder must be ≤ 1.00 Diopters (D) in each eye. * The subject must have best corrected visual acuity of 20/25 or better in each eye. * The subject should own a wearable pair of spectacles and bring to initial visit. * The subject must be an adapted frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes. * The subject must have normal eyes (i.e., no ocular medications or infections of any type). * The subject must have enrolled and completed all visits in clinical study (NCT02515994).
Exclusion criteria
* Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). * Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g., hepatitis, tuberculosis). * Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g., Accutane), oral tetracyclines, topical scopolamine, oral phenothiazines (e.g. Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or OTC ocular medication. * Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion. * Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.) * Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. * Any known hypersensitivity or allergic reaction to Opti-Free® PureMoist® multipurpose care solution or Eye-Cept rewetting drop solution * Any ocular infection, allergy or clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study. * Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * Daily disposables, extended wear, monovision or multi-focal contact lens correction. * History of binocular vision abnormality or strabismus. * Employee or relative of employees of sponsor or investigational clinic (e.g., Investigator, Coordinator, Technician)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eyes Grade 3 or Higher SLF | Up to 6 Month Follow-up | Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The proportion of subject eyes with SLF grade 3 or higher was reported for each lens. |
| Visual Acuity (logMAR) | Up to 6 Month Follow-up | The visual acuity (LogMAR) was collected at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The average Visual Acuity (logMAR) across the 4 study visits and at each individual visit was reported for each lens. |
Countries
United States
Participant flow
Pre-assignment details
A total of 105 subjects were enrolled into this study. Of the enrolled subjects all were dispensed a study lens. Out of all the dispensed subjects 103 completed the study while 2 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Senofilcon C Subjects that wore the senofilcon C lens throughout the entire duration of the study. | 49 |
| Comfilcon A Subjects that wore the comfilcon A lens throughout the entire duration of the study. | 56 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
Baseline characteristics
| Characteristic | Senofilcon C | Comfilcon A | Total |
|---|---|---|---|
| Age, Continuous | 31.2 Years STANDARD_DEVIATION 7.03 | 31.5 Years STANDARD_DEVIATION 7.31 | 31.4 Years STANDARD_DEVIATION 7.15 |
| Race/Ethnicity, Customized Asian | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 43 Participants | 52 Participants | 95 Participants |
| Region of Enrollment United States | 49 Participants | 56 Participants | 105 Participants |
| Sex: Female, Male Female | 36 Participants | 35 Participants | 71 Participants |
| Sex: Female, Male Male | 13 Participants | 21 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 56 |
| serious Total, serious adverse events | 0 / 49 | 0 / 56 |
Outcome results
Primary
Proportion of Eyes Grade 3 or Higher SLF
Slit lamp findings were graded using a FDA Grade Scale, 0 = None, 1 = Slight, 2 = Moderate, 3 = Significant, 4 = Advanced. Measurements were taken in each subject eye at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The proportion of subject eyes with SLF grade 3 or higher was reported for each lens.
Time frame: Up to 6 Month Follow-up
Population: Subjects that were dispensed a study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon C | Proportion of Eyes Grade 3 or Higher SLF | 0 Proporiton of Subject Eyes |
| Comfilcon A | Proportion of Eyes Grade 3 or Higher SLF | 0 Proporiton of Subject Eyes |
Primary
Visual Acuity (logMAR)
The visual acuity (LogMAR) was collected at the initial visit, 4 month, 5 month and 6 month follow-up evaluations. This study is a continuation of a previous study therefore data from the initial visit was included in reporting. The average Visual Acuity (logMAR) across the 4 study visits and at each individual visit was reported for each lens.
Time frame: Up to 6 Month Follow-up
Population: Subjects that completed all study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Senofilcon C | Visual Acuity (logMAR) | 5 Month Follow-up N=94, N=112 | -0.13 LogMAR | Standard Deviation 0.068 |
| Senofilcon C | Visual Acuity (logMAR) | Overall N=376, N=448 | -0.12 LogMAR | Standard Deviation 0.066 |
| Senofilcon C | Visual Acuity (logMAR) | Initial Visit N=94, N=112 | -0.14 LogMAR | Standard Deviation 0.069 |
| Senofilcon C | Visual Acuity (logMAR) | 4 Month Follow-up N=94, N=112 | -0.12 LogMAR | Standard Deviation 0.069 |
| Senofilcon C | Visual Acuity (logMAR) | 6 Month Follow-up N=94, N=112 | -0.12 LogMAR | Standard Deviation 0.063 |
| Comfilcon A | Visual Acuity (logMAR) | 6 Month Follow-up N=94, N=112 | -0.13 LogMAR | Standard Deviation 0.072 |
| Comfilcon A | Visual Acuity (logMAR) | 4 Month Follow-up N=94, N=112 | -0.13 LogMAR | Standard Deviation 0.075 |
| Comfilcon A | Visual Acuity (logMAR) | Overall N=376, N=448 | -0.12 LogMAR | Standard Deviation 0.074 |
| Comfilcon A | Visual Acuity (logMAR) | 5 Month Follow-up N=94, N=112 | -0.12 LogMAR | Standard Deviation 0.078 |
| Comfilcon A | Visual Acuity (logMAR) | Initial Visit N=94, N=112 | -0.13 LogMAR | Standard Deviation 0.064 |