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

Completed · Not applicable

Conditions studied: Refractive Error

In brief

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.

Key facts

Study ID

NCT02515994

Run by

Johnson & Johnson Vision Care, Inc.

People needed

224

Starts

2015-07-01

Expected to finish

2015-11-01

Last updated by the study team

2016-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: 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 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

You may not qualify if…

• 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)

Where it is running

• Vue Optical Boutique — Jacksonville, Florida, United States
• Omega Vision Center, PA / Sabal Eye Care — Longwood, Florida, United States
• Eyecare Associates — Bloomington, Illinois, United States
• Advantage Eyecare Associates, LLC — Broadway Pittsburg, Kansas, United States
• Dr. Debbie H. Kim, OD — Closter, New Jersey, United States
• Sacco Eye Group — Vestal, New York, United States
• Pickens Family Eye Care — Pickens, South Carolina, United States
• Premier Vision — Amarillo, Texas, United States
• William J. Bogus OD — Salt Lake City, Utah, United States
• Timothy R. Poling, OD — Salem, Virginia, United States

Full record on ClinicalTrials.gov

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