Pilot Clinical Evaluation of Approved Contact Lenses

Overview

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.

Full Title of Study: “Imaging of Conjunctival Microvasculature During Contact Lens Wear”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2016

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

  • Device: Marketed Contact Lens 1
    • Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
  • Device: Marketed Contact Lens 2
    • Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
  • Device: Marketed Contact Lens 3
    • Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
  • Device: Marketed Contact Lens 4
    • Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).

Arms, Groups and Cohorts

  • Active Comparator: Subject A (Neophytes)
    • Subjects will wear the Marketed Contact Lens 1, Marketed Contact Lens 2, Marketed Contact Lens 3, and Marketed Contact Lens 4 for a 6-hour period in a bilateral and random fashion, with a washout period of one week between lenses. Each subject will randomly be assigned to one of four unique sequences of a 4 x 4 crossover design. A block size of two sequences will be used.
  • Active Comparator: Subject B (Habitual Lens Wearers)
    • Subjects will wear the Marketed Contact Lens 1, Marketed Contact Lens 2, Marketed Contact Lens 3, and Marketed Contact Lens 4 for a 6-hour period in a bilateral and random fashion, with a washout period of one week between lenses. Each subject will randomly be assigned to one of four unique sequences of a 4 x 4 crossover design. A block size of two sequences will be used.

Clinical Trial Outcome Measures

Primary Measures

  • Assessment of Bulbar Conjunctival Blood Flow Velocity
    • Time Frame: 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.

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Johnson & Johnson Vision Care, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hong Jiang, MD, PhD, Principal Investigator, University of Miami

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