Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population

NCT04567186 | Completed Results FDA Device

• 1 other identifier: CR-6392
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 7

Brief Summary

This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial that will last approximately 2 - 4 months.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Binocular Visual Acuity (logMAR)

  Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale and was evaluated at distance (4 meters), intermediate (64 cm) and near (40 cm) under high lumiance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be beetween 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.

  1-Week Follow-up

Secondary Outcomes (1)

• Subjective Overall Vision Scores

  1- Week Follow-up

Study Arms (2)

Test/Control/Control

EXPERIMENTAL

Eligible subjects that are habitual soft contact lens wearers will be randomized to lens wear sequence, (Test/Control/Control).

Device: Investigational senofilcon A C3 Multifocal Lens; Device: delefilcon A Multifocal Lens

Control/Test/Test

EXPERIMENTAL

Eligible subjects that are habitual soft contact lens wearers will be randomized to lens wear sequence, (Control/Test/Test).

Device: Investigational senofilcon A C3 Multifocal Lens; Device: delefilcon A Multifocal Lens

Interventions

Investigational senofilcon A C3 Multifocal Lens DEVICE

TEST

Control/Test/Test; Test/Control/Control

delefilcon A Multifocal Lens DEVICE

Dailies Total 1® Multifocal Contact Lens

Also known as: CONTROL

Control/Test/Test; Test/Control/Control

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 at least 40 years of age and not greater than 70 years of age at the time of consent.
• Subjects must own a wearable pair of spectacles if required for their distance vision.
• The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration).
• 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).
• The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D in each eye.
• The subject's refractive cylinder must be ≤0.75 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 distance best corrected 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 ocular or systemic allergies that may interfere with contact lens wear.
• 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, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
• Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
• A history of amblyopia, strabismus or binocular vision abnormality.
• Use of any of the following medications within 2 weeks prior to enrollment: oral retinoids, oral tetracyclines, anticholinergics, systemic/topical steroids, oral phenothiazines. See section 9.1 for additional details regarding excluded systemic medications.
• Use of any ocular medication, with the exception of rewetting drops.
• History of herpetic keratitis.
• History of irregular cornea.
• History of pathological dry eye.
• Participation in any contact lens or lens care product clinical trial within 30 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 non-preserved rewetting drop solutions or sodium fluorescein.
• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (7)

Empire Eye and Laser Center

Bakersfield, California, 93309, United States

Location

James R. Dugue, OD

Mission Viejo, California, 92691, United States

Location

Stame & Associates, Eye Care

Jacksonville, Florida, 32256, United States

Location

VRC-East

Jacksonville, Florida, 32256, United States

Location

St. Johns Eye Associates, PA

Saint Augustine, Florida, 32092, United States

Location

Spectrum Eyecare

Jamestown, New York, 14701, United States

Location

Eye Associates of New York

Manhattan, New York, 10022, United States

Location

Results Point of Contact

• Title: Thomas R. Karkkainen, OD, MS, FAAO, Sr. Principal Research Optometrist
• Organization: Johnson & Johnson Vision Care Inc.

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 28, 2020
• Study Start: September 6, 2020
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: January 21, 2022
• Results First Posted: January 21, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

US (7)