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Senofilcon A Investigational Manufacturing Process
Senofilcon A Investigational Manufacturing Process
CompletedNA
Sponsor: Johnson & Johnson Vision Care, Inc.
Conditions: Visual Acuity, Comfort, Overall Vision
Interventions: senofilcon A, senofilcon A
Countries: United States
To evaluate the impact of a new contact lens hydration process
Eligibility overview
Sex: ALL
Age: 18 Years to 70 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
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 and not more than 70 years of age. * The subject's refractive cylinder must be \< 0.75D in each eye. * The subject must have best corrected visual acuity of 20/25 or better in each eye. * The subject must demonstrate adequate mobility and 20/30 vision OD and OS with the study contact lenses. * The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens in both eyes. * The subject must have normal eyes (i.e., no ocular medications or infections of any type). * The subject's required spherical contact lens prescription must be in the range of -0.50 to -9.00D in each eye. Exclusion Criteria: * Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued). * Any ocular or systemic allergies or diseases that may interfere with contact lens wear. * Any systemic disease, autoimmune disease, or use of medication, that may interfere with contact lens wear. * 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, PRK, 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® Contact Lens Solution. * Any ocular infection. * Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * Monovision or multi-focal contact lens correction. * Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment. * History of binocular vision abnormality or strabismus. * Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report). * Suspicion of or recent history of alcohol or substance abuse. * History of serious mental illness. * History of seizures. * Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Locations (4)
- Jacksonville, Florida, United States
- Bloomington, Illinois, United States
- Pittsburg, Kansas, United States
- Warwick, Rhode Island, United States