Evaluation of Approved Contact Lenses

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Acuity

Treatments: Device: B+L Infuse spherical soft contact lenses; Device: J&J ACUVUE OASYS 1-Day spherical soft contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT07174596

CR-6617

Details and patient eligibility

About

This is a prospective, randomized, controlled, subject-masked, bilateral, dispensing, multi-site, 2 lenses × 3 wearing periods crossover study to evaluate visual acuity.

Enrollment: 85 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

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

3. Be between 18 and 39 (inclusive) years of age at the time of screening. 4. 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.

5. Have a habitual contact lens prescription that is current (no power change needed) within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.

6. Possess a wearable pair of spectacles that provide correction for distance vision.

7. The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D in each eye.

8. 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:

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 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.
4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
5. Be currently wearing monovision or multifocal contact lenses.
6. Be currently wearing lenses in an extended wear modality.
7. Have a known hypersensitivity or allergic reaction to silicone hydrogel soft contact lenses.
8. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
9. 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.
10. 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).
11. Have a history of strabismus or amblyopia.
12. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
13. 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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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85 participants in 2 patient groups

Test/Control/Control

Experimental group

Description:

Eligible subjects will be randomized to the test/control/control sequence, to wear the test lens, the control lens, and the control lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day.

Treatment:

Device: J&J ACUVUE OASYS 1-Day spherical soft contact lenses

Device: B+L Infuse spherical soft contact lenses

Control/Test/Test

Experimental group

Description:

Eligible subjects will be randomized to the control/test/test sequence, to wear the control lens, the test lens, and the test lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day.

Treatment:

Device: J&J ACUVUE OASYS 1-Day spherical soft contact lenses

Device: B+L Infuse spherical soft contact lenses