Assessment of Contact Lens Wettability Using Wavefront Aberrometry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink
Study Overview
Brief Summary
This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
senofilcon A
The lenses will be worn for 2 hours in both eyes, and not dispensed
Intervention: senofilcon A (Device)
senofilcon A
The lenses will be worn for 2 hours in both eyes, and not dispensed
Intervention: lotrafilcon B (Device)
lotrafilcon A
The lenses will be worn for 2 hours in both eyes, and not dispensed
Intervention: senofilcon A (Device)
lotrafilcon A
The lenses will be worn for 2 hours in both eyes, and not dispensed
Intervention: lotrafilcon B (Device)
Outcomes
Primary Outcomes
Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink
Time Frame: 2 hours post insertion
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.
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink
Time Frame: 2 hours post insertion
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.
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking
Time Frame: 2 hours post insertion
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.
Secondary Outcomes
No secondary outcomes reported