Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision Correction of Presbyopia

NCT04073186 | Completed Results FDA Device

• 1 other identifier: CR-6349
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 5

Brief Summary

This is a single-masked, dispensing clinical trial. A total of approximately 48 myopic and 32 hyperopic eligible subjects will be targeted to complete the study. Subjects will be fit in the study lens, optimized if required and worn for approximately 2 weeks. Subjects will then have a washout period of approximately 1 week and be refit in the lenses and be dispensed for an additional 2 weeks of wear.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Vision Scores

  Vision Scores were assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

  2-Week Follow-up

• Visual Performance (logMAR)

  Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 meters), intermediate (64 centimeters) and near (40 centimeters) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be etween 7.3 and 7.9 EV (394-597 lux). For Distance (4 meters), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64 cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

  2-Week Follow-up

Secondary Outcomes (1)

• CLUE Vision Comparison Between First Wearing Cycle and Second Wearing Cycle

  Up to 2-Week Follow-up

Study Arms (1)

ACUVUE® OASYS with Transitions™

EXPERIMENTAL

Eligible subjects between the ages of 40 to 70 years of age and habitual wearers of soft contact lenses will be fitted with the study lens for two wearing cycles.

Device: ACUVUE® OASYS with Transitions™

Interventions

ACUVUE® OASYS with Transitions™ DEVICE

JJVC Marketed Contact Lens

ACUVUE® OASYS with Transitions™

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects must satisfy all the following criteria to be enrolled in the study:
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• The subject must be between 40 and 70 years of age at the time of screening.
• Subjects must own a wearable pair of spectacles if required for their distance vision.
• The subject must be an adapted monovision soft contact lens wearer in both eyes (i.e., worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration).
• The subject's distance spherical equivalent refraction must be in the range of +3.50 D to -4.00 D in each eye.
• The subject's refractive cylinder must be ≤1.00 D in each eye.
• The subject's ADD power must be in the range of +0.75 D to +2.50 D.
• The subject must have best corrected distance visual acuity of 20/20-3 or better in each eye.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Currently Pregnant or lactating.
• 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, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g., hepatitis, tuberculosis).
• Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), systemic steroids.
• Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, dacryocystorhinostomy, etc.).
• Use of any ocular medication, with the exception of rewetting drops.
• Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• Any known hypersensitivity or allergic reaction to OPTI-FREE® Puremoist® care cleaning solution, non-preserved rewetting drop solution or sodium fluorescein.
• History of herpetic keratitis.
• Entropion, ectropion, chalazia, glaucoma, history of recurrent corneal erosions.
• A history of amblyopia, strabismus or binocular vision abnormality.
• Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
• Any ocular infection or inflammation.
• Any ocular abnormality that may interfere with contact lens wear.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (5)

VRC-East

Jacksonville, Florida, 32256, United States

Location

Advanced Eyecare

Raytown, Missouri, 64133, United States

Location

Manhattan Vision Associates

New York, New York, 10022, United States

Location

Western Reserve Vision Care, Inc.

Beachwood, Ohio, 44122, United States

Location

Dr. David W. Ferris & Associates

Warwick, Rhode Island, 02886, United States

Location

Results Point of Contact

• Title: Thomas Karkkainen- Sr. Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care

TKarkkai@its.jnj.com

1-800-843-2020

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: August 29, 2019
• Study Start: August 7, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: August 10, 2022
• Results First Posted: May 18, 2021

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

US (5)