The Effects of Contact Lenses With UV/HEV-Filter on Visual Function

Last updated: April 24, 2025
Sponsor: Johnson & Johnson Vision Care, Inc.
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

ACUVUE OASYS MAX 1-Day Multifocal

ACUVUE OASYS MAX 1-Day

ACUVUE OASYS Multifocal

Clinical Study ID

NCT05601544
CR-6480
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a 2-phase, single-site, non-dispensing, randomized, controlled, double-masked, 2x2 crossover study to objectively measure potential benefits of a new UV/HEV filter using psychophysical testing techniques.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

The subject must:

  1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fullyexecuted copy of the form.

  2. Appear able and willing to adhere to the instructions set forth in this clinicalprotocol.

  3. Be between 18 and 70 (inclusive) years of age at the time of screening.

  4. By self-report, habitually wear soft contact lenses (sphere, multifocal, toric) inboth eyes in a daily reusable or daily disposable wear modality (i.e. not extendedwear 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.

  5. If applicable, those subjects receiving the spherical lenses will need avertex-corrected distance refraction within the range of -1.00 through -6.00 DS

  6. If applicable, those subjects receiving the multifocal lenses will need avertex-corrected distance refraction within the range of -1.00 through -6.00 DS

  7. If applicable, those subjects receiving the toric lenses will need avertex-corrected distance refraction within the range of -1.50 through -4.00 DS, -0.625 through -1.625 DC, and cylinder axes: 80/90/100, 170/180/10

  8. The best corrected, monocular, distance visual acuity must be 20/25 or better ineach eye

Exclusion

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

The subject must not:

  1. Be currently pregnant or lactating.

  2. Be currently using any ocular medications or have any ocular infection of any type.

  3. By self-report, have any ocular or systemic disease, allergies, infection, or use ofmedication that the investigator believes might contraindicate or interfere withcontact lens wear, or otherwise compromise study endpoints, including infectiousdisease (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.

  4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, orhybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.

  5. Be currently wearing lenses in an extended wear modality.

  6. Have participated in a contact lens or lens care product clinical trial within 14days prior to study enrollment.

  7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate familymember of an employee (including partner, child, parent, grandparent, grandchild orsibling of the employee or their spouse) of the clinical site.

  8. (Phase 2 only): Have participated in Phase 1 of the study.

  9. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lampfindings (e.g., corneal edema, neovascularization or staining, tarsal abnormalitiesor bulbar injection) or other corneal or ocular disease or abnormalities that theinvestigator believes might contraindicate contact lens wear or may otherwisecompromise study endpoints (including entropion, ectropion, chalazia, recurrentstyes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or abovecorneal distortion, herpetic keratitis).

  10. Have a history of strabismus or amblyopia.

  11. Have fluctuations in vision due to clinically significant dry eye or other ocularconditions.

  12. 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.).

Study Design

Total Participants: 145
Treatment Group(s): 6
Primary Treatment: ACUVUE OASYS MAX 1-Day Multifocal
Phase:
Study Start date:
December 09, 2022
Estimated Completion Date:
November 17, 2023

Connect with a study center

  • The University of Georgia

    Athens, Georgia 30602
    United States

    Site Not Available

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