Assessment of Contact Lens Wettability Using Wavefront Aberrometry

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

Study Overview

• Status: Completed
• Conditions: Visual Acuity
• Intervention / Treatment: Device: lotrafilcon B; Device: senofilcon A

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Kelvin Grove, Queensland, Australia, 4059

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy males or females that are at least 18 to no more than 40 years of age.
2. The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
4. The subject must possess a wearable pair of spectacles with distance vision correction which provide satisfactory vision.
5. 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).
6. The subject's vertexed best sphere distance refraction must be between -0.75 and -5.00 D in both eyes.
7. Cylinder refraction less than or equal to -0.75 D in both eyes (any axis).
8. The subject must have corrected visual acuity of 20/20 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any known hypersensitivity or allergic reaction to contact lens solutions or sodium fluorescein dye.
5. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
6. Current wearers of rigid or hybrid contact lenses.
7. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
8. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
9. History of binocular vision abnormality or strabismus.
10. Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician).
11. 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.
12. Strabismus, suppression or amblyopia.
13. Any ocular infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): January 28, 2015

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CR-5685