Clinical trial NCT04534517: Clinical Evaluation of a Daily Wear Reusable Multifocal Optical Design in a Presbyopic Population
Official title: Clinical Evaluation of a Daily Wear Reusable Multifocal Optical Design in a Presbyopic Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-01
Enrollment: 119
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Vision Scores
timeFrame: 2-Week Follow-up
measure: Visual Performance LogMAR
timeFrame: 2-Week Follow-up
measure: Proportion of Eyes With Unacceptable Lens Fitting
timeFrame: Up to 2-Week Follow-up
measure: Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings
timeFrame: Up to 2-Week Follow-up
Secondary outcomes:
measure: Proportion of Eyes That Achieved Optimal Lens Pair in 4 Lenses or Less
timeFrame: Up to 2-Week Follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Dr. James Weber & Associates, PA
state: Florida
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Maitland
country: United States
facility: Maitland Vision Center
state: Florida
city: Roswell
country: United States
facility: VisualEyes
state: Georgia
city: Bloomington
country: United States
facility: VisionPoint Eye Center
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Raytown
country: United States
facility: Advanced Eyecare
state: Missouri
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Granville
country: United States
facility: ProCare Vision Centers
state: Ohio
city: Warwick
country: United States
facility: Dr. David W. Ferris & Associates
state: Rhode Island
city: Tyler
country: United States
facility: Frazier Vision Inc.
state: Texas
Study officials:
References: