Clinical trial NCT01951703: Senofilcon A Investigational Manufacturing Process
Official title: Clinical Investigation of Senofilcon A Manufactured Using an Alternate Hydration Process
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Comfort
Overall Vision
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2013-09-27
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the impact of a new contact lens hydration process

Detailed 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.

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 \< 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)

Primary outcomes:
measure: Subjective Overall Comfort (Using CLUE )
timeFrame: 2 weeks
measure: Subjective Overall Vision (Using CLUE )
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
state: Florida
city: Bloomington
country: United States
state: Illinois
city: Pittsburg
country: United States
state: Kansas
city: Warwick
country: United States
state: Rhode Island
Study officials:
affiliation: Johnson & Johnson Vision Care
name: Brian Pall, OD
role: STUDY_DIRECTOR
References: