Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes in Myopes

NCT04889625 | Completed Results FDA Device

• 1 other identifier: CR-6444
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 6

Brief Summary

This is a single-masked, 2×3 crossover, randomized controlled, dispensing clinical trial to evaluate the visual performance (logMAR) and subjective vision responses of the Test Lens.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  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 (HLHC) lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 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 (64cm) 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)

• Overall Vision

  1-Week Follow-up

Study Arms (2)

Test/Control/Control

EXPERIMENTAL

Eligible subjects will be randomized to one of two possible lens wear sequences, Test/Control/Control.

Device: senofilcon A C3; Device: Dailies Total 1® Multifocal Contact Lenses

Control/Test/Test

EXPERIMENTAL

Eligible subjects will be randomized to one of two possible lens wear sequences, Control/Test/Test.

Device: senofilcon A C3; Device: Dailies Total 1® Multifocal Contact Lenses

Interventions

senofilcon A C3 DEVICE

Test Lens

Control/Test/Test; Test/Control/Control

Dailies Total 1® Multifocal Contact Lenses DEVICE

Control Lens

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, diabetes, 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 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See section 9.1 for further examples.
• 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 3 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 (6)

Vue Optical Boutique

Jacksonville, Florida, 32205, United States

Location

St. Johns Eye Associates

Saint Augustine, Florida, 32092, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Procare Vision Centers

Granville, Ohio, 43023, United States

Location

Gulf Coast Vision Center

Houston, Texas, 77054, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Results Point of Contact

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

TKarkkai@its.jnj.com

1-904-254-0152

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

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: May 12, 2021
• First Posted: May 17, 2021
• Study Start: May 21, 2021
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: July 20, 2022
• Results First Posted: July 20, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

US (6)