Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population

NCT03742271 | Completed Results FDA Device

• 1 other identifier: CR-6241
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 11

Brief Summary

This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally fit with the test article for approximately 4 weeks of reusable daily wear with lens replacement occurring 2-weeks after initial dispensing. After 4 weeks of study lens wear, subjects will return to their habitual spectacles for one week.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Acceptable Lens Fitting

  Acceptable fit is determined by the eye care practitioner (ECP/investigator) and includes the following criteria; (1) physiological responses (No Grade 3 or higher slit lamp findings), (2) mechanical lens fitting (no unacceptable lens fitting in either eye), (3) subjects' assessment of comfort, vision and handling.

  4-Week Follow-up

Study Arms (1)

senofilcon A

EXPERIMENTAL

Subjects that are habitual spectacle wearers that have never worn contact lenses and have had an eye exam and an updated spectacle prescription in the last 6 months will be enrolled and fitted into the senofilcon A TEST Lens for a total period of 4 weeks.

Device: senofilcon A

Interventions

senofilcon A DEVICE

TEST Lens

senofilcon A

Eligibility Criteria

• Age: 18 Years - 39 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 39 (inclusive) years of age at the time of screening.
• They are a contact lens 'neophyte'. In this work 'neophyte' is taken to mean any subject who has never been dispensed contact lenses. A subject who had taken part in a non-dispensing clinical study or had been fitted with contact lenses in practice but never went on to actually wear the lenses, is also classified as a 'neophyte'.
• Habitual spectacles must have resulted from an eye exam within the past six months.
• The subject must have worn the updated spectacles for at least two weeks.
• Be a current wearer of prescription spectacles that provide corrected monocular visual acuity of 20/25 or better in each eye.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
• The subject's refractive cylinder must be -1.00 D or less in each eye.
• Have spherocylindrical best corrected distance Snellen visual acuity of 20/25 or better in each eye.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating
• Currently pregnant or lactating.
• Any active or ongoing 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 that have a high likelihood to interfere with contact lens wear (estrogens, antihistamines, anticholinergics, beta-blockers, and psychotropics).
• Any current use of ocular medication.
• Any known hypersensitivity or allergic reaction to any ingredient in Opti-Free PureMoist.
• Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• 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 Grade 3 or 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit lamp classification scale.
• Binocular vision abnormality or strabismus.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (11)

Vue Optical Boutique

Jacksonville, Florida, 32205, United States

Location

Atlantic Eye Institute

Jacksonville Beach, Florida, 32250, United States

Location

Sabal Eye Care

Longwood, Florida, 32792, United States

Location

Baker Vision Care

Macclenny, Florida, 32063, United States

Location

Georgia Center for Sight

Greensboro, Georgia, 30642, United States

Location

Advanced Eyecare

Raytown, Missouri, 64133, United States

Location

ABQ Eye Care

Albuquerque, New Mexico, 87109, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

Eyecare Professionals of Powell

Powell, Ohio, 43065, United States

Location

Frazier Vision Inc.

Tyler, Texas, 75703, United States

Location

Results Point of Contact

• Title: John Buch OD F.A.A.O- Sr. Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care Inc.

JBUCH@its.jnj.com

+1 904 443-1707

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 15, 2018
• Study Start: October 30, 2018
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: March 13, 2020
• Results First Posted: March 13, 2020

Record last verified: 2020-02

Locations

US (11)