Senofilcon A Investigational Manufacturing Process
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 6/21/2018 |
Start Date: | September 2013 |
End Date: | December 2013 |
Clinical Investigation of Senofilcon A Manufactured Using an Alternate Hydration Process
To evaluate the impact of a new contact lens hydration process
To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an
alternate hydration process and compare the performance with senofilcon A lenses manufactured
using the current process.
alternate hydration process and compare the performance with senofilcon A lenses manufactured
using the current process.
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 < 0.75D in each eye.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
- The subject must demonstrate adequate mobility and 20/30 vision OD and OS with the
study contact lenses.
- The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens
in both eyes.
- The subject must have normal eyes (i.e., no ocular medications or infections of any
type).
- The subject's required spherical contact lens prescription must be in the range of
-0.50 to -9.00D in each eye.
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, or moderate or above corneal distortion by
keratometry.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK,
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 known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens
Solution.
- 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)
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