Evaluation of Etafilcon A Daily Disposable Lenses



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 70
Updated:6/21/2018
Start Date:January 2014
End Date:March 2014

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Clinical Evaluation of Two Etafilcon A Daily Disposable Lenses

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


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)
We found this trial at
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