Clinical Performance of Senofilcon A Investigational Lens

NCT05300763 | Completed Results FDA Device

• 1 other identifier: CR-6481
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 19

Brief Summary

This study is a controlled, randomized, subject-masked, 2-arm parallel, 2-week dispensing, bilateral evaluation where the study lenses are worn for a minimum of 5 days per week and 6 hours per day.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• End of Day Comfort

  End of day comfort was assessed using an individual item "Comfort at the End of the Day". Response set: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, Dissatisfied, and Very Dissatisfied.

  2-Week Follow-up

Secondary Outcomes (3)

• Digital Device Use

  2-Week Follow-up

• Comfort Throughout the Day

  2-Week Follow-up

• Comfortable Vision While Night Driving

  2-Week Follow-up

Study Arms (2)

TEST LENS

EXPERIMENTAL

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

Device: senofilcon A prototype

CONTROL LENS

EXPERIMENTAL

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

Device: Dailies Total 1

Interventions

senofilcon A prototype DEVICE

Test

TEST LENS

Dailies Total 1 DEVICE

Control

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:
• 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.
• 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 wear 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.
• Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
• 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 20/25or better in each eye.

You may not qualify if:

• The subject must not:
• 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.
• Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
• 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 30 days prior to study enrollment.
• The subject must not:
• 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 might 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 a history of strabismus or amblyopia.
• 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 (19)

Randall Go, OD

San Francisco, California, 94110, United States

Location

Vue Optical Boutique

Jacksonville, Florida, 32205, United States

Location

Dr. James Weber & Associates, PA - City Square Blvd

Jacksonville, Florida, 32218, United States

Location

Stam & Associates Eye Care

Jacksonville, Florida, 32256, United States

Location

Sabal Eye Care

Longwood, Florida, 32779, United States

Location

Maitland Vision Center - North Orlando Ave

Maitland, Florida, 32751, United States

Location

Flora Chen Poveda, OD, PA - Orange Park

Orange Park, Florida, 32073, United States

Location

Southwest Orlando Eye Care

Orlando, Florida, 32819, United States

Location

Tallahassee Eye Center

Tallahassee, Florida, 32308, United States

Location

VisualEyes

Roswell, Georgia, 30076, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Birmingham Vision Care

Bloomfield, Michigan, 48301, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

Dr. David W. Ferris & Associates

Warwick, Rhode Island, 02888, United States

Location

Optometry Group, LLC

Memphis, Tennessee, 38111, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Botetourt Eyecare, LLC

Salem, Virginia, 24153, United States

Location

Results Point of Contact

• Title: John R. Buch, Senior Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care, Inc.

jbuch@its.jnj.com

1-800-843-2020

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: March 21, 2022
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: June 22, 2023
• Results First Posted: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (19)