CompletedInterventionalNot ApplicableUpdated Aug 12, 2020
Evaluation of Etafilcon A Daily Disposable Lenses | NCT02061592 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 19, 2018
Evaluation of Etafilcon A Daily Disposable Lenses
Clinical Evaluation of Two Etafilcon A Daily Disposable Lenses
ClinicalTrials.gov ID
NCT02061592
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
136Actual
Last Update Posted
Jun 19, 2018Actual
Start Date
Jan 2014
Primary Completion Date
Mar 2014Actual
Completion Date
Mar 2014Actual
Official Title
Clinical Evaluation of Two Etafilcon A Daily Disposable Lenses
Brief Summary
To evaluate the clinical performance of daily disposable etafilcon A lenses.
Myopia
etafilcon A
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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 < 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.
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.
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)