Evaluation of a Johnson & Johnson Vision Care Investigational Contact Lens Compared to a Marketed Monthly Replacement Contact Lens

Study Overview
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Brief Summary
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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
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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.

Conditions
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Refractive Error

Intervention / Treatment
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* Device: senofilcon C
* Device: comfilcon A


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: senofilcon C<br>JJVCI investigational contact lens daily wear replacement. | Device: senofilcon C<br>* Investigational contact lens<br>|
| Active Comparator: comfilcon A<br>Marketed contact lens daily wear replacement. | Device: comfilcon A<br>* Marketed Monthly Replacement Lens (Control)<br>* Other names: Biofinity;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 3 Month Follow-up | 
| 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. | Up to 3 month Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 3 month Follow-up | 
| 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. | 3 month Follow-up |