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 |
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
7
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials