Evaluation of Prototype Lenses With Experimental UV/HEV Blocker

NCT04885296 | Completed Results FDA Device

• 1 other identifier: CR-6437
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 12

Brief Summary

This is a bilateral, 2-week dispensing, randomized, controlled, subject-masked, 2×2 crossover study to evaluate the clinical performance of prototype contact lenses with experimental UV/HEV-blocker.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (1)

• Overall Quality of Vision Score

  Overall quality of 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. The average CLUE vision score for each lens type was reported.

  2-Week Follow-up

Secondary Outcomes (2)

• Overall Comfort Scores

  2-Week Follow-up

• Overall Handling Scores

  2-Week Follow-up

Study Arms (2)

Test/Control

EXPERIMENTAL

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

Device: TRP-200; Device: JJVC Marketed Contact Lens

Control/Test

EXPERIMENTAL

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

Device: TRP-200; Device: JJVC Marketed Contact Lens

Interventions

TRP-200 DEVICE

JJVC Investigational Contact Lens

Also known as: TEST Lens

Control/Test; Test/Control

JJVC Marketed Contact Lens DEVICE

ACUVUE Oasys 1-Day

Also known as: CONTROL Lens

Control/Test; Test/Control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Be between 18 and 39 (inclusive) years of age at the time of screening.
• By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
• Have a habitual contact lens prescription that is current within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 through -6.00 D (except -5.00 D) in both eyes.
• The subject's refractive cylinder must be 1.00 D or less.
• The subject must have best corrected visual acuity of 20/25 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:
• Be currently pregnant or lactating.
• Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Have any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
• Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• Be currently wearing lenses in a monovision, multi-focal, toric, or extended wear modality.
• Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
• Have a history of binocular vision abnormality or strabismus.
• Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
• Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
• Have any ocular infection.
• Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (12)

Dr. James Weber & Associates, PA

Jacksonville, Florida, 32205, United States

Location

Flora Chen Poveda, OD, PA

Orange Park, Florida, 32073, United States

Location

Tallahassee Eye Center

Tallahassee, Florida, 32308, United States

Location

Visual Eyes

Roswell, Georgia, 30075, United States

Location

Birmingham Vision Care

Bloomfield Township, Michigan, 48301, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Dr. Debbie H. Kim, OD

Closter, New Jersey, 07624, United States

Location

Professional Vision Care, Inc.

Westerville, Ohio, 43081, United States

Location

Optometry Group, LLC

Memphis, Tennessee, 38111, United States

Location

Gulf Coast Vision Center, Inc.

Houston, Texas, 77054, United States

Location

Frazier Vision, Inc.

Tyler, Texas, 75703, United States

Location

Botetourt Eyecare, LLC

Salem, Virginia, 24153, United States

Location

Results Point of Contact

• Title: John R. Buch, O.D., M.S., F.A.A.O.
• Organization: Johnson & Johnson Vision Care, Inc.

jbuch@its.jnj.com

904-608-7238

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 10, 2021
• First Posted: May 13, 2021
• Study Start: May 10, 2021
• Primary Completion: August 9, 2021
• Study Completion: August 9, 2021
• Last Updated: September 1, 2022
• Results First Posted: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

US (12)