Evaluation of Electronic LogMar Visual Acuity and Contrast Sensitivity in a Population of Contact Lens Wearers

NCT03222037 | Completed Phase 4 Results FDA Device

• 1 other identifier: CR-5968
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This is a bilateral, non-dispensing, randomized, cross-over, single-masked study. There are a total of 3 visits where all study endpoints will be measured in all subjects at baseline with habitual lenses and under the two testing treatments sequentially in separate visits based on the randomization scheme

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Visual Acuity (logMAR)

  Visual Acuity was collected electronically under two conditions (high luminance low contrast and low luminance high contrast) in both eyes 15- minutes post study article administration. The average visual acuity for each lens type and condition was reported.

  15 Minutes post Treatment Administration

Secondary Outcomes (1)

• Area Under Contrast Sensitivity Function Curve

  15 minutes post treatment administration

Study Arms (2)

TEST/SCR

EXPERIMENTAL

Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (TEST/SCR) sequentially

Device: senofilcon A; Device: Control

SCR/TEST

EXPERIMENTAL

Subjects who are current soft contact lens wearers between the ages of 18 and 35 will be randomized to the two different treatments (SCR/TEST) sequentially

Device: senofilcon A; Device: Control

Interventions

senofilcon A DEVICE

Acuvue Oasys 1-Day

SCR/TEST; TEST/SCR

Control DEVICE

Trial Frame with best spherocylindrical refraction (SCR)

SCR/TEST; TEST/SCR

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 35 (inclusive) years of age at the time of screening
• The subject must be habitual contact lens wearers (defined as minimum 6 hours per day, 5 days a week over the last month)
• The subject must meet all of the following three criteria:
• The eyes' spherical equivalent distance refraction must be in the range of -1.00 to -9.00 D (inclusive)
• The eyes' refractive cylinder must be less than or equal to -0.75 DC
• Each eye must have best corrected visual acuity of 20/25 or better.
• The subject must have normal eyes (i.e., no ocular medications or infections of any type)

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Currently pregnant or lactating
• Any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study
• Use of systemic medications (e.g., chronic steroid use) that are known to interfere with contact lens wear or may impact the functioning of the tear film (e.g., Isotretinoin)
• Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion
• Any current use of ocular medication
• Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
• Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron 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 would contraindicate contact lens wear
• Any known hypersensitivity or allergic reaction to contact lens care products.
• Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment
• Employee of clinical site (e.g., Investigator, Coordinator, Technician)
• Current wearers of Acuvue Oasys 1-Day brand contact lenses

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

VRC East

Jacksonville, Florida, 32256, United States

Location

Results Point of Contact

• Title: Chantal Coles-Brennan -PRINCIPAL RESEARCH OPTOMETRIST
• Organization: Johnson & Johnson Vision Care, INC.

CColesb@its.jnj.com

1-904-443-3449

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 19, 2017
• Study Start: June 27, 2017
• Primary Completion: August 4, 2017
• Study Completion: August 4, 2017
• Last Updated: September 10, 2019
• Results First Posted: August 24, 2018

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)