Senofilcon A Investigational Manufacturing Process

Completed · Not applicable

Conditions studied: Visual Acuity, Comfort, Overall Vision

In brief

To evaluate the impact of a new contact lens hydration process

Key facts

Study ID

NCT01951703

Run by

Johnson & Johnson Vision Care, Inc.

People needed

136

Starts

2013-09-01

Expected to finish

2013-12-01

Last updated by the study team

2018-06-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Study site — Jacksonville, Florida, United States
• Study site — Bloomington, Illinois, United States
• Study site — Pittsburg, Kansas, United States
• Study site — Warwick, Rhode Island, United States

Full record on ClinicalTrials.gov

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