Clinical trial NCT02540122: Pilot Clinical Evaluation of Approved Contact Lenses
Official title: Imaging of Conjunctival Microvasculature During Contact Lens Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Vision Disorders
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-03
Enrollment: 30
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: TREATMENT

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.

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 \< 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)

Primary outcomes:
measure: Assessment of Bulbar Conjunctival Blood Flow Velocity
timeFrame: 4 contact lenses will be tested over a period of 21 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Hong Jiang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: