Senofilcon A Investigational Manufacturing Process
Status
Completed
Conditions
Overall Vision
Comfort
Visual Acuity
Treatments
Device: senofilcon A
Details and patient eligibility
About
To evaluate the impact of a new contact lens hydration process
Full description
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.
Enrollment
136 patients
Sex
All
Ages
18 to 70 years old
Volunteers
No Healthy Volunteers
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)
Trial design
Primary purpose
Supportive Care
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
136 participants in 2 patient groups
Control, senofilcon A
Active Comparator group
Description:
Subjects received Control lens, senofilcon A during the first two weeks of the study then Test lens, senofilcon A in the last two weeks of the study.
Treatment:
Device: senofilcon A
Device: senofilcon A
Test, senofilcon A
Experimental group
Description:
Subjects received Test lens, senofilcon A during the first two weeks of the study then Control lens, senofilcon A in the last two weeks of the study.
Treatment:
Device: senofilcon A
Device: senofilcon A
Trial contacts and locations
4
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Data sourced from clinicaltrials.gov
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