Design Validation of Toric Contact Lenses in Senofilcon A With a Blue-Blocking Chromophore

NCT05778786 | Completed Results FDA Device

• 1 other identifier: CR-6521
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 10

Brief Summary

This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treatment, 2-sequence, 2-period crossover study.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (6)

• Distance Monocular logMAR Visual Acuity

  Distance Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. Visual acuity is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. 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

• CLUE Vision Score

  Subjective vision was 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.

  1-Week Follow-up

• Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees

  Absolute rotation was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.

  15-minutes after lens insertion

• Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees

  Rotational Stability was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was report for each lens.

  15-minutes after lens insertion

• Proportion of Eyes With Acceptable Lens Fitting

  Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable lens fit=0. The proportion of eyes with acceptable lens fit was reported for each lens.

  Up to 1-Week Follow-up

• Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings

  Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported for each lens.

  Up to 1-Week Follow-up

Secondary Outcomes (2)

• CLUE Comfort Score

  1-Week Follow-up

• CLUE Handling Score

  1-Week Follow-up

Study Arms (2)

Test/Control

EXPERIMENTAL

Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to wear bilaterally two different study lenses, one at a time, for a minimum of 8 hours per day for at least 5 days during each wear period, over two wear periods (test then control) with a washout period of 7+/-2 days duration between wear periods.

Device: Acuvue Oasys 1 Day for Astigmatism; Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore

Control/Test

EXPERIMENTAL

Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to wear bilaterally two different study lenses, one at a time, for a minimum of 8 hours per day for at least 5 days during each wear period, over two wear periods (control then test) with a washout period of 7+/-2 days duration between wear periods.

Device: Acuvue Oasys 1 Day for Astigmatism; Device: TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore

Interventions

Acuvue Oasys 1 Day for Astigmatism DEVICE

CONTROL

Control/Test; Test/Control

TRA100/TRA200 series toric contact lens with HEVL-blocking chromophore DEVICE

TEST

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:
• The subject must:
• 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 years of age (inclusive) at the time of screening.
• Habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e., not extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum of 2 days per week during the past four weeks.
• Possess a wearable pair of spectacles that provide correction for distance vision.
• In both eyes, have refractive error suitable for correction with the toric contact lens powers available in this study:
• Sphere powers (DS) -1.50 through -4.00 in 0.25 steps
• Cylinder powers (DC) -0.75 and -1.25
• Axes (°) 170, 180, 10, 80, 90, 100
• Have best corrected monocular distance visual acuity of 20/30 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:
• The subject must not:
• Be currently pregnant or lactating.
• Be diabetic.
• Be currently using any ocular medications or have an ocular infection of any type.
• By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
• Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
• Be currently wearing monovision or multifocal contact lenses.
• Be currently wearing lenses in an extended wear modality.
• Have a history of strabismus or amblyopia.
• 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 participated in a contact lens or lens care product clinical trial within 7 days prior to study enrollment.
• Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
• Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
• Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (10)

Stam & Associates Eye Care

Jacksonville, Florida, 32256, United States

Location

Omega Vision Center

Longwood, Florida, 32779, United States

Location

Maitland Vision Center - North Orlando Ave

Maitland, Florida, 32751, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

Professional Vision Care Inc. - Westerville

Westerville, Ohio, 43081, United States

Location

Optometry Group, LLC

Memphis, Tennessee, 38111, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Botetourt Eyecare, LLC

Salem, Virginia, 24153, United States

Location

Results Point of Contact

• Title: Benjamin Straker
• Organization: Johnson & Johnson Vision Care, Inc. (JJVC)

bstraker@its.jnj.com

1-800-843-2020

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: March 10, 2023
• First Posted: March 21, 2023
• Study Start: March 13, 2023
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: July 17, 2024
• Results First Posted: July 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

US (10)