The Effects of Contact Lenses With Experimental Dye on Visual Function

This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Device: senofilcon A with new UV blocker; Device: senofilcon A

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Statesboro, Georgia, United States, 30642
      • Georgia Center for Sight

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol
3. Between 18 and 65 (inclusive) years of age at the time of screening.
4. Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
5. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 D in each eye.
6. The subject has a best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or breastfeeding.
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Multifocal, toric or extended wear contact lens correction.
8. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
9. History of binocular vision abnormality or strabismus.
10. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
11. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
12. Any ocular infection.
13. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test/Control; For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again.	Device: senofilcon A with new UV blocker; Test Lens; Device: senofilcon A; Control Lens
Experimental: Control/Test; For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again.	Device: senofilcon A with new UV blocker; Test Lens; Device: senofilcon A; Control Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two-Point Light Spread Function	The two-point light spread function was assessed at visit 2 for each subject eye under two conditions with a distance filter and without a distance filter. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Two-point light spread function is defined that the as the minimum distance (mm) that two points of light are completely distinct. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and light source combination was reported across age groups.	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
Halos	The appearance of Halos was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Halos were quantified as the diameter (mm) of the outer edges of the Halo. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
Starburts	The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glare Disability Threshold	The Glare disability threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported across age groups.	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Photostress Recovery Time	Photostress Recovery (PR) Time (seconds) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects are exposed to a target, once the target was able to be comfortable viewed by the subject, a bright bleaching light covered it. As the afterimage fades, participants will gradually be able to re-gain sight of the target. PR time will be recorded as the time it takes following exposure to the bleaching light to regain sight of the target. PR Times are positive values where smaller times indicate better lens performance. The average PR Time (seconds) for each lens type was reported across age groups.	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Glare Discomfort	The Glare discomfort (change in palpebral fissure height) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported across age groups.	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Heterochromatic Contrast Threshold	Heterochromatic Contrast Threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Heterochromatic contrast thresholds are measured as thresholds to a variable wavelength central target presented on a short-wave (460nm) sky-light background. Thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported across age groups.	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2018
• Primary Completion (Actual): September 20, 2018
• Study Completion (Actual): September 20, 2018

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: October 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CR-6100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes