The Effects of Contact Lenses With Experimental Dye on Visual Function

NCT03556579 | Completed Results FDA Device

• 1 other identifier: CR-6100
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ametropia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Glare Disability Threshold

  Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1

• Photostress Recovery Time

  Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1

• Glare Discomfort

  Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1

• Heterochromatic Contrast Threshold

  Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1

Study Arms (2)

Test/Control

EXPERIMENTAL

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; Device: senofilcon A

Control/Test

EXPERIMENTAL

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; Device: senofilcon A

Interventions

senofilcon A with new UV blocker DEVICE

Test Lens

Control/Test; Test/Control

senofilcon A DEVICE

Control Lens

Control/Test; Test/Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol
• Between 18 and 65 (inclusive) years of age at the time of screening.
• 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.
• The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 D in each eye.
• The subject has a best corrected visual acuity of 20/25 or better in each eye.

You may not qualify if:

• Currently pregnant or breastfeeding.
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• 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.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Multifocal, toric or extended wear contact lens correction.
• Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• Any ocular infection.
• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Georgia Center for Sight

Statesboro, Georgia, 30642, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: John Buch, O.D. F.A.A.O - Senior Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care Inc.

JBUCH@its.jnj.com

904-443-1707

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 14, 2018
• Study Start: May 15, 2018
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-10

Locations

US (1)