Evaluation of Approved Contact Lenses (CR-6657)

NCT07819305 | Recruiting FDA Device

• 1 other identifier: CR-6657
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

Brief Summary

This is a prospective, multi-site, bilateral, 2-week dispensing, randomized, controlled, single-masked (subjects), 2x2 crossover study to evaluate visual acuity.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Binocular High Luminance, Low Contrast (HLLC) Distance (4 meters) Visual Acuity (logMAR) at 2-week Follow-up

  At 2-week follow-up

Study Arms (2)

Test/Control

EXPERIMENTAL

Eligible subjects will be randomized to the Test/Control sequence, to wear the Test Lens for approximately 2 weeks, undergo a 2-week washout period, and then wear the Control lens for approximately 2 weeks.

Device: Test (Senofilcon A); Device: Control (Serafilcon A)

Control/Test

EXPERIMENTAL

Eligible subjects will be randomized to the Control/Test sequence, to wear the Control Lens for approximately 2 weeks, undergo a 2-week washout period, and then wear the Test lens for approximately 2 weeks.

Device: Test (Senofilcon A); Device: Control (Serafilcon A)

Interventions

Test (Senofilcon A) DEVICE

Test Lens

Control/Test; Test/Control

Control (Serafilcon A) DEVICE

Precision7®

Control/Test; Test/Control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The vertex corrected subjective best sphere distance refraction must be between -1.00 D and -6.00 D (inclusive) in each eye.
• The magnitude of the cylindrical component of the subject's vertex corrected distance refraction must be less than or equal to 1.00 D (inclusive) in each eye with any degree of axis.
• The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.
• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Be currently pregnant or lactating.
• Be diabetic.
• Have any current ocular infection of any type.
• Be currently using any ocular medications. The use of topical ophthalmic allergy medications may be acceptable provided the medication regimen has remained stable for at least 14 days prior to enrollment and is expected to remain unchanged throughout study participation. All ophthalmic medications must be administered according to the approved product labeling, including any instructions regarding contact lens removal and reinsertion. Any changes in medication type, dose, frequency, duration, or administration instructions during the study will be documented and may result in a protocol deviation or study discontinuation.
• Routinely require or use artificial tears, lubricant eye drops, or contact lens rewetting drops for successful contact lens wear. Subjects with occasional, non-routine use may be enrolled provided they self-report discontinuation prior to enrollment and agree to refrain from their use during the study. Use of artificial tears, lubricant eye drops, or contact lens rewetting drops during a study lens wear period is not permitted. Any such use during the study will be documented and may result in a protocol deviation or study discontinuation.
• 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) contact lenses, orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months.
• Be currently wearing monovision, multifocal, or toric soft contact lenses.
• Be currently wearing lenses in an extended wear modality.
• Have a self-reported history of allergy, hypersensitivity, or intolerance to any study product or ancillary supply that, in the Investigator's judgment, could interfere with study participation or evaluation of study endpoints.
• Have participated in a contact lens or lens care product trial within 14 days prior to study enrollment.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (8)

VRC

Jacksonville, Florida, 32256, United States

ACTIVE NOT RECRUITING

Franklin Park Eye Center, P.C.

Franklin Park, Illinois, 60131, United States

RECRUITING

Eyecare Center of Camden

Camden, New York, 13316, United States

NOT YET RECRUITING

ProCare Vision Centers

Granville, Ohio, 43023, United States

RECRUITING

New Bremen EyeCare

New Bremen, Ohio, 45869, United States

NOT YET RECRUITING

Total Eye Care

Memphis, Tennessee, 38119, United States

RECRUITING

Paradigm Research Center, LLC

Houston, Texas, 77030, United States

NOT YET RECRUITING

Botetourt Eyecare, LLC

Salem, Virginia, 24153, United States

RECRUITING

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

1-800-843-2020; ANixon1@ITS.JNJ.com

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: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 10, 2026
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (8)