Clinical Long-Term Evaluation of Approved and Investigational Contact Lenses

Study Overview
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Brief Summary
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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.

Conditions
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Visual Disorders

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 (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)

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>Vistakon Investigational Contact Lens (Test) | Device: senofilcon C<br> <br> |
| Active Comparator: comfilcon A<br>Marketed Monthly Wear Contact Lens (Control) | Device: comfilcon A<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 Month Follow-up | 
| 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. | Up to 6 Month Follow-up |