Assessment of Contact Lens Wettability Using Wavefront Aberrometry

• ClinicalTrials.gov Identifier: NCT02349438
• Recruitment Status: Completed
• First Posted: January 28, 2015
• Results First Posted: January 20, 2017
• Last Update Posted: June 19, 2018
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Visual Acuity	Device: senofilcon A; Device: lotrafilcon B	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Study Start Date: December 2014
• Actual Primary Completion Date: May 2015
• Actual Study Completion Date: May 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Australia, Queensland

Kelvin Grove, Queensland, Australia, 4059

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT02349438
• Other Study ID Numbers: CR-5685
• First Posted: January 28, 2015
• Results First Posted: January 20, 2017
• Last Update Posted: June 19, 2018
• Last Verified: November 2016