Evaluation of Etafilcon A Daily Disposable Lenses

Completed · Not applicable

Conditions studied: Myopia

In brief

To evaluate the clinical performance of daily disposable etafilcon A lenses.

Key facts

Study ID

NCT02061592

Run by

Johnson & Johnson Vision Care, Inc.

People needed

136

Starts

2014-01-01

Expected to finish

2014-03-01

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 < 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's required spherical contact lens prescription must be in the range of -0.50 to -7.50 D in each eye.
• The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes.
• The subject must self-report their race as Asian
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).
• The subject must demonstrate adequate mobility and 20/30 vision oculus dexter (OD) and oculus sinister (OS) with the study contact lenses.

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.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser 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 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 — Honolulu, Hawaii, United States
• Study site — Kahului, Hawaii, United States
• Study site — Waipahu, Hawaii, United States
• Study site — ‘Aiea, Hawaii, United States
• Study site — New York, New York, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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