Evaluation of Prototype Lenses With Experimental UV/HEV Blocker

Visual Acuity Clinical Trial

Official title:

Evaluation of Prototype Lenses With Experimental UV/HEV Blocker

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04885296
• Other study ID #: CR-6437
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: August 9, 2021

Study information

• Verified date: August 2022
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: August 9, 2021
• Est. primary completion date: August 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• TRP-200
JJVC Investigational Contact Lens
• JJVC Marketed Contact Lens
ACUVUE Oasys 1-Day

Locations

Country	Name	City	State
United States	Birmingham Vision Care	Bloomfield Township	Michigan
United States	Dr. Debbie H. Kim, OD	Closter	New Jersey
United States	Gulf Coast Vision Center, Inc.	Houston	Texas
United States	Dr. James Weber & Associates, PA	Jacksonville	Florida
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Optometry Group, LLC	Memphis	Tennessee
United States	Flora Chen Poveda, OD, PA	Orange Park	Florida
United States	Visual Eyes	Roswell	Georgia
United States	Botetourt Eyecare, LLC	Salem	Virginia
United States	Tallahassee Eye Center	Tallahassee	Florida
United States	Frazier Vision, Inc.	Tyler	Texas
United States	Professional Vision Care, Inc.	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Comfort Scores	Overall comfort 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 comfort score for each lens type was reported.	2-Week Follow-up
Secondary	Overall Handling Scores	Overall handling 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 handling score for each lens type was reported.	2-Week Follow-up