Evaluation of Prototype Lenses With Experimental UV/HEV Blocker

NCT ID: NCT04885296

Last Updated: 2022-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2021-08-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Test/Control

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

Group Type: EXPERIMENTAL

TRP-200

Intervention Type: DEVICE

JJVC Investigational Contact Lens

JJVC Marketed Contact Lens

Intervention Type: DEVICE

ACUVUE Oasys 1-Day

Control/Test

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

Group Type: EXPERIMENTAL

TRP-200

Intervention Type: DEVICE

JJVC Investigational Contact Lens

JJVC Marketed Contact Lens

Intervention Type: DEVICE

ACUVUE Oasys 1-Day

Interventions

TRP-200

JJVC Investigational Contact Lens

Intervention Type: DEVICE

JJVC Marketed Contact Lens

ACUVUE Oasys 1-Day

Intervention Type: DEVICE

Other Intervention Names

TEST Lens; CONTROL Lens

Eligibility Criteria

Inclusion Criteria

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. Be between 18 and 39 (inclusive) years of age at the time of screening.

4. 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.

5. 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.

6. 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.

7. The subject's refractive cylinder must be 1.00 D or less.

8. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Be currently pregnant or lactating.

2. Have any ocular or systemic allergies or diseases that may interfere with contact lens wear.

3. 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.

4. Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

5. Be currently wearing lenses in a monovision, multi-focal, toric, or extended wear modality.

6. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.

7. 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.

8. Have a history of binocular vision abnormality or strabismus.

9. Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.

10. 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.

11. Have any ocular infection.

12. Have any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

13. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Vision Care, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Vision Care, Inc.

Locations

Dr. James Weber & Associates, PA

Jacksonville, Florida, United States

Flora Chen Poveda, OD, PA

Orange Park, Florida, United States

Tallahassee Eye Center

Tallahassee, Florida, United States

Visual Eyes

Roswell, Georgia, United States

Birmingham Vision Care

Bloomfield Township, Michigan, United States

Complete Eye Care of Medina

Medina, Minnesota, United States

Dr. Debbie H. Kim, OD

Closter, New Jersey, United States

Professional Vision Care, Inc.

Westerville, Ohio, United States

Optometry Group, LLC

Memphis, Tennessee, United States

Gulf Coast Vision Center, Inc.

Houston, Texas, United States

Frazier Vision, Inc.

Tyler, Texas, United States

Botetourt Eyecare, LLC

Salem, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CR-6437

Identifier Type: -

Identifier Source: org_study_id