Comparison of Two Silicone Hydrogel Multifocal Contact Lenses

NCT04093258 | Completed Results FDA Device

• 1 other identifier: CR-6344
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief Summary

This is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 40 eligible hyperopic and myopic subjects will be targeted to complete the study. The subjects will be fit in the first study lens and worn for a total of 8-12 days following a 7±3 day wash-out period. The procedures will be repeated for the 2nd lens.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Lens Centration

  Lens centration was assessed using a biomicroscope and was graded using the scale (Grade: 0, 1,2) with grade 0 represent Centered, Grade 1 = Slightly Decentered and Grade 2= substantially decentered. The data was then dichotomized into two groups: those with grade 1 or higher and those with grade 0 (centered). The percentage of participants with Grade 0 Lens centration was reported.

  6 to 8 days

• Percentage of Participants With Lens Movement

  Lens movement in primary gaze was assessed using a biomicroscope and was graded using the scale (Insufficient/Unacceptable (-2), Minimal/Acceptable (-1), Optimal (0), Moderate/Acceptable (+1) and Excessive/Unacceptable (+2)) with Optimal (0) representing no lens movement. The data was then dichotomized into two groups: those with Optimal Lens movement and otherwise (-2, -1, +1 and +2). The percentage of participants with Optimal Lens movement was reported.

  6 to 8 days

Secondary Outcomes (1)

• Overall Handling Scores

  6 to 8 days

Study Arms (2)

Test/Control

EXPERIMENTAL

Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting.

Device: Dailies Total 1® Multifocal Contact Lenses; Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde®

Control/Test

EXPERIMENTAL

Eligible subjects between 40-70 years of age who are habitual soft contact lens wearers and hyperopic or myopic and have presbyopia will be randomized to one of two sequences (Test/Control or Control/Test) with a 4-10 day washout period in between each fitting.

Device: Dailies Total 1® Multifocal Contact Lenses; Device: Air Optix® Multifocal Contact Lenses Plus HydraGlyde®

Interventions

Dailies Total 1® Multifocal Contact Lenses DEVICE

TEST

Control/Test; Test/Control

Air Optix® Multifocal Contact Lenses Plus HydraGlyde® DEVICE

CONTROL

Control/Test; Test/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 between 40 and 70 years of age (inclusive).
• The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D or -1.25 D to -4.00 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 best corrected visual acuity of 20/20-3 or better in each eye.
• 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 8 hours per wear day, for 1 month of 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".

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, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
• 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.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
• Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, cataract surgery, retinal surgery, etc.).
• A history of amblyopia, strabismus or binocular vision abnormality.
• Any current ocular infection or inflammation.
• Any current ocular abnormality that may interfere with contact lens wear.
• Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids.
• Use of any ocular medication, with the exception of rewetting drops.
• History of herpetic keratitis.
• 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).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (3)

Visual Eyes

Roswell, Georgia, 30076, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

Optometry Group, LLC

Memphis, Tennessee, 38111, United States

Location

Results Point of Contact

• Title: Thomas R. Karkkainen, OD, MS, FAAO
• 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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: August 26, 2019
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: December 1, 2021
• Results First Posted: February 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

US (3)