Pilot Clinical Evaluation of Approved Contact Lenses

Study Overview
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Brief Summary
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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
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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.

Official Title
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Imaging of Conjunctival Microvasculature During Contact Lens Wear

Conditions
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Vision Disorders

Intervention / Treatment
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* Device: Marketed Contact Lens 1
* Device: Marketed Contact Lens 2
* Device: Marketed Contact Lens 3
* Device: Marketed Contact Lens 4


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subject A (Neophytes)<br>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. | Device: Marketed Contact Lens 1<br>* Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).<br>* Other names: etafilcon A;Device: Marketed Contact Lens 2<br>* Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).<br>* Other names: nelfilcon A;Device: Marketed Contact Lens 3<br>* Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).<br>* Other names: narafilcon A in 8.5 base curve;Device: Marketed Contact Lens 4<br>* Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).<br>* Other names: narafilcon A in 9.0 base curve;|
| Active Comparator: Subject B (Habitual Lens Wearers)<br>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. | Device: Marketed Contact Lens 1<br>* Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).<br>* Other names: etafilcon A;Device: Marketed Contact Lens 2<br>* Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).<br>* Other names: nelfilcon A;Device: Marketed Contact Lens 3<br>* Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).<br>* Other names: narafilcon A in 8.5 base curve;Device: Marketed Contact Lens 4<br>* Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).<br>* Other names: narafilcon A in 9.0 base curve;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Bulbar Conjunctival Blood Flow Velocity | 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. | 4 contact lenses will be tested over a period of 21 days. |