Clinical Evaluation of a Daily Wear Reusable Multifocal Optical Design in a Presbyopic Population

Johnson & Johnson (J&J)

Status: Completed

Conditions: Visual Acuity

Treatments: Device: ACUVUE OASYS® with HYDRACLEAR® PLUS; Device: JJV Investigational Multifocal Contact Lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT04534517

CR-6400

Details and patient eligibility

About

The clinical study is a bilateral, single-masked (partial), single-arm, clinical trial. A total of approximately 60 eligible subjects both near-sighted and far-sighted, will be targeted to complete the study. Subjects will be fit in the study lens for approximately 2-4 days then undergo lens optimization, if required. Subjects will then be given a new pair of lenses that will be worn for approximately 2 weeks.

Enrollment: 119 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be at least 40 years of age and not greater than 70 years of age at the time of consent.
4. Subjects must own a wearable pair of spectacles if required for their distance vision.
5. The subject must be an adapted soft contact lens wearer in both eyes (i.e. wears lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month of more duration).
6. The subject must either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire" (Appendix E).
7. The subject's distance spherical equivalent refraction (vertex corrected if ≥-4.25 D) must be in the range of -1.25 D to -5.75 D or +0.75 D to +3.25 D in each eye.
8. The subject's refractive cylinder must be ≤0.75 D in each eye.
9. The subject's ADD power must be in the range of +0.75 D to +2.50 D.
10. The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye.

Exclusion criteria

1. Currently pregnant or lactating.
2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
4. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, peripheral iridotomy/iridectomy, cataract surgery, retinal surgery, etc.).
5. A history of amblyopia, strabismus or binocular vision abnormality.
6. History of glaucoma, macular degeneration, recurrent corneal erosions, recurrent styes, herpetic keratitis, irregular cornea or pathological dry eye.
7. Use of any of the following medications within 1 week prior to enrollment: oral retinoids, oral tetracyclines, oral phenothiazines, anticholinergics, corticosteroids.
8. Use of any ocular medication, with the exception of rewetting drops.
9. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
11. Any known hypersensitivity or allergic reaction to Optifree® Replenish® multipurpose care solution, sodium fluorescein or non-preserved rewetting drop solutions.
12. Clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
13. Any current ocular infection or inflammation.
14. Any current ocular abnormality that may interfere with contact lens wear.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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119 participants in 1 patient group

TEST Lens

Experimental group

Description:

Eligible subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age will be recruited. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.

Treatment:

Device: JJV Investigational Multifocal Contact Lens

Device: ACUVUE OASYS® with HYDRACLEAR® PLUS