Refractive Error
Conditions
Brief summary
Randomized, double-masked, controlled, 2-arm parallel group, multi-site, 3-month dispensing study of Johnson & Johnson Vision Care, Inc. (JJVCI) Investigational contact lens, compared with a marketed, monthly replacement contact lens. Subjects will wear the JJVCI investigational contact lenses on a daily wear basis.
Detailed description
Objective of the study is to demonstrate the safety and efficacy of the JJVCI investigational contact lens by comparison to the marketed, monthly replacement contact lens, both worn for thirty days on a daily wear modality.
Interventions
DEVICEsenofilcon C
Investigational contact lens
DEVICEcomfilcon A
Marketed Monthly Replacement Lens (Control)
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 in each eye. * The subject must have best corrected visual acuity of 20/25 or better in each eye. * Subjects should own a wearable pair of spectacles. * 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). * Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 4 days per week
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 (e.g. Seldane, Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, 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 over the counter (OTC) ocular medication. * 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 in situ keratomileusis (LASIK), etc.). * Any grade 2 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 Optifree®Puremoist® multi-purpose 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. * Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment. * 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 |
|---|---|---|
| Slit Lamp Findings | Up to 3 Month Follow-up | Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported. |
| Visual Acuity | Up to 3 month Follow-up | Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms | Up to 3 month Follow-up | Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item Experienced Eye Symptoms or Problems? were reported. |
| Average Wear Time | 3 month Follow-up | Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported. |
Countries
United States
Participant flow
Pre-assignment details
A total of 224 subjects were enrolled in this study. Of the enrolled subjects 3 did not meet the eligibility criteria and 221 were dispensed a study lens. Of the dispensed subjects 204 completed the study while 17 subjects were discontinued.
Participants by arm
| Arm | Count |
|---|---|
| Senofilcon C Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study. | 109 |
| Comfilcon A Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study. | 112 |
| Total | 221 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | No Longer Meets Eligibility Criteria | 2 | 1 |
| Overall Study | Protocol Violation | 3 | 5 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Senofilcon C | Comfilcon A | Total |
|---|---|---|---|
| Age, Continuous | 30.4 years STANDARD_DEVIATION 7.26 | 30.9 years STANDARD_DEVIATION 7.33 | 30.7 years STANDARD_DEVIATION 7.24 |
| Region of Enrollment United States | 109 participants | 112 participants | 221 participants |
| Sex: Female, Male Female | 79 Participants | 71 Participants | 150 Participants |
| Sex: Female, Male Male | 30 Participants | 41 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 109 | 5 / 112 |
| serious Total, serious adverse events | 0 / 109 | 0 / 112 |
Outcome results
Primary
Slit Lamp Findings
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported.
Time frame: Up to 3 Month Follow-up
Population: All subjects that were dispensed a study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon C | Slit Lamp Findings | 3 Eyes |
| Comfilcon A | Slit Lamp Findings | 2 Eyes |
Primary
Visual Acuity
Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported.
Time frame: Up to 3 month Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon C | Visual Acuity | -0.11 LogMAR | Standard Deviation 0.073 |
| Comfilcon A | Visual Acuity | -0.12 LogMAR | Standard Deviation 0.073 |
Secondary
Average Wear Time
Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported.
Time frame: 3 month Follow-up
Population: Subjects that completed all study visits without a major protocol deviation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Senofilcon C | Average Wear Time | 14.88 Hours per day | Standard Deviation 1.713 |
| Comfilcon A | Average Wear Time | 14.90 Hours per day | Standard Deviation 1.576 |
Secondary
Symptoms
Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item Experienced Eye Symptoms or Problems? were reported.
Time frame: Up to 3 month Follow-up
Population: All subjects that were dispensed a study lens.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Senofilcon C | Symptoms | 153 Eyes |
| Comfilcon A | Symptoms | 225 Eyes |