Clinical trial NCT02699593: Clinical Evaluation of Approved Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-04
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test and control lenses in random succession. The objective is to evaluate materials from different suppliers.


Eligibility criteria: Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be at least 18 and not more than 70 years of age (including 70).
4. The subject's refractive cylinder must be \< 0.75 Diopters (D) in each eye.
5. The subject must have best corrected visual acuity of 20/25 or better in each eye.
6. The subject must be a habitual and adapted wearer of ACUVUE® OASYS® brand contact lens in both eyes (at least 1 month of daily wear).
7. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
8. The subject's required spherical contact lens prescription must be in the range of -1.00 D to -6.00 D in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia.
5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
6. 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.
7. Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.
8. Any ocular infection.
9. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
10. Monovision or multi-focal contact lens correction.
11. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
12. History of binocular vision abnormality or strabismus.
13. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
14. Suspicion of or recent history of alcohol or substance abuse.
15. History of serious mental illness.
16. History of seizures.
17. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Primary outcomes:
measure: Contact Lens Wearing Time
timeFrame: 2-week follow-up
measure: Visual Acuity (LogMAR)
timeFrame: 2-week Follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Jacksonville
country: United States
facility: Eye Elements Eyecare
state: Florida
city: Sarasota
country: United States
facility: Golden Vision
state: Florida
city: Neodesha
country: United States
facility: Advantage Eyecare Associates, LLC
state: Kansas
city: Raytown
country: United States
facility: Advanced Eyecare, PC
state: Missouri
city: Westerville
country: United States
facility: Professional Vision Care
state: Ohio
city: Roanoke
country: United States
facility: Timothy R. Poling, OD
state: Virginia
Study officials:
References: