Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology to Evaluate Overall Visual Acuity.

NCT05361304 | Completed Results FDA Device

• 1 other identifier: CR-6474
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 6

Brief Summary

This study is a feasibility, multi-site, randomized, double-masked, 2-arm parallel group design, 2-week dispensing study with weekly visits to evaluate visual acuity.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Monocular logMAR Visual Acuity

  Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance low contrast (HLLC), and low luminance high contrast (LLHC) at distance (4 meters) using an ETDRS (Early Treatment Diabetic Retinopathy Study) charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

  2-Week Follow-up

• Average Daily Wearing Time

  Average daily wear time was assessed by calculating the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day.

  2-Week Follow-up

Secondary Outcomes (2)

• CLUE Comfort Score

  2-Week Follow-up

• CLUE Vision Score

  2-Week Follow-up

Study Arms (2)

TEST Lens

EXPERIMENTAL

Eligible subjects who are habitual soft contact lens wearers will be randomized into the TEST Lens for the duration of the study.

Device: senofilcon A contact lenses made with a novel manufacturing technology

CONTROL Lens

EXPERIMENTAL

Eligible subjects who are habitual soft contact lens wearers will be randomized into the CONTROL Lens for the duration of the study.

Device: senofilcon A contact lenses made with the current manufacturing technology

Interventions

senofilcon A contact lenses made with a novel manufacturing technology DEVICE

TEST Lens

TEST Lens

senofilcon A contact lenses made with the current manufacturing technology DEVICE

CONTROL Lens

CONTROL Lens

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:
• 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.
• Be between 18 and 39 (inclusive) years of age at the time of screening.
• By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
• Possess a wearable pair of spectacles that provide correction for distance vision.
• The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 and -6.00 DS (inclusive) in each eye.
• The magnitude of the cylindrical component of the subject's vertex-corrected distance refraction must be between 0.00 and 1.00 DC (inclusive) in each eye.
• The best corrected, monocular, distance visual acuity must be 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 in the study:
• Be currently pregnant or lactating.
• Be currently using any ocular medications or have any ocular infection of any type.
• By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
• Be currently wearing monovision or multifocal contact lenses.
• Be currently wearing lenses in an extended wear modality.
• Have participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
• Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
• Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes will contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). (Specify method of determination if needed).
• Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
• Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (6)

VRC

Jacksonville, Florida, 32256, United States

Location

Flora Chen Poveda OD, PA - Orange Park

Orange Park, Florida, 32073, United States

Location

Tallahassee Eye Center

Tallahassee, Florida, 32308, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

William J. Bogus, O.D.

Salt Lake City, Utah, 84106, United States

Location

Botetourt Eyecare, LLC

Salem, Virginia, 24153, United States

Location

Results Point of Contact

• Title: John R. Buch, OD, MS, FAAO
• Organization: Johnson & Johnson Vision Care, Inc. (JJVC)

jbuch@its.jnj.com

800-843-2020

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: May 16, 2022
• Primary Completion: July 5, 2022
• Study Completion: July 5, 2022
• Last Updated: July 13, 2023
• Results First Posted: July 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (6)