Vision Disorders
Conditions
Brief summary
This is a pilot evaluation to assess the feasibility of using novel imaging process to characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.
Detailed description
This is a pilot evaluation to assess the feasibility of using ultra-high resolution optical coherence tomography (OCT) to image and characterize lens edge and limbal epithelial thickness profile; lens movement with gaze and blink; and conjunctival microvasculature including fractal analysis of microvascular perfusion maps and blood flow velocity.
Interventions
DEVICEMarketed Contact Lens 1
Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
DEVICEMarketed Contact Lens 2
Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
DEVICEMarketed Contact Lens 3
Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
DEVICEMarketed Contact Lens 4
Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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 must be either a neophyte or a habitual and adapted wearer of soft contact lenses in both eyes. * 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-assisted 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Bulbar Conjunctival Blood Flow Velocity | 4 contact lenses will be tested over a period of 21 days. | Bulbar conjunctival microvascular responses among different types of contact lenses after a period of lens wear will be observed and evaluated for clinical relevance findings. |
Countries
United States
Outcome results
None listed