Clinical Evaluation of Approved and Investigational Contact Lenses Using New UV Additive

Completed · Not applicable

Conditions studied: Visual Acuity

In brief

Randomized, 8-visit dispensing study over 14 weeks to evaluate the safety and efficacy of an investigational contact lens with a new UV blocker compared to a marketed contact lens.

Key facts

Study ID

NCT02982018

Run by

Johnson & Johnson Vision Care, Inc.

People needed

133

Starts

2016-10-01

Expected to finish

2017-02-18

Last updated by the study team

2018-07-19

Who can join

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

You may qualify if…

• The subject must read and sign the Informed Consent form.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Healthy adult males or females age ≥ 18 years of age with signed informed consent. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them.
• The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 6.00 Diopters (D).
• The subject's refractive cylinder must be ≤ 1.00 D in each eye.
• The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
• Subjects should own a wearable pair of spectacles.
• The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of Daily Wear per day, at least 5 days per week, for a minimum of 1 month prior to the study) and willing to wear the study lenses on a similar basis.
• Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).

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-assisted 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.
• Toric, 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

• Study site — Jacksonville, Florida, United States
• Study site — Longwood, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Closter, New Jersey, United States
• Study site — Vestal, New York, United States
• Study site — Pickens, South Carolina, United States

Full record on ClinicalTrials.gov

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