Assessment of Contact Lens Wettability Using Wavefront Aberrometry

Study Overview
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Brief Summary
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This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: senofilcon A
* Device: lotrafilcon B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or females that are at least 18 to no more than 40 years of age. 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 possess a wearable pair of spectacles with distance vision correction which provide satisfactory vision. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of lens wear per week for a minimum of 1 month prior to the study) or has sufficient prior experience with soft contact lens wear (defined as a minimum of 30 days of lens wear during the last 5 years). The subject's vertexed best sphere distance refraction must be between -0.75 and -5.00 D in both eyes. Cylinder refraction less than or equal to -0.75 D in both eyes (any axis). The subject must have corrected visual acuity of 20/20 or better in each eye. 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, which may interfere with contact lens wear. Any known hypersensitivity or allergic reaction to contact lens solutions or sodium fluorescein dye. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.) Current wearers of rigid or hybrid contact lenses. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV). History of binocular vision abnormality or strabismus. Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician). Clinically significant (grade 3 or 4) corneal edema, pterygium, corneal vascularization, corneal staining, or any other abnormalities of the cornea or conjunctiva which may interfere with the study measurements. Strabismus, suppression or amblyopia. Any ocular infection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: senofilcon A<br>The lenses will be worn for 2 hours in both eyes, and not dispensed | Device: senofilcon A<br>* A soft spherical contact lens<br>Device: lotrafilcon B<br> <br> |
| Active Comparator: lotrafilcon A<br>The lenses will be worn for 2 hours in both eyes, and not dispensed | Device: senofilcon A<br>* A soft spherical contact lens<br>Device: lotrafilcon B<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking | Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome. | 2 hours post insertion | 
| Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink | Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome. | 2 hours post insertion | 
| Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink | Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome. | 2 hours post insertion |