Assessment of Contact Lens Wettability Using Wavefront Aberrometry

Visual Acuity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349438
• Other study ID #: CR-5685
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: May 2015

Study information

• Verified date: November 2016
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• senofilcon A
A soft spherical contact lens
• lotrafilcon B

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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