Feasibility Evaluation of Daily Disposable Toric Soft Contact Lenses Manufactured With an Alternative Hydration Process

NCT05427539 | Completed Results FDA Device

• 1 other identifier: CR-6482
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 6

Brief Summary

This is a bilateral wear, dispensing, randomized, controlled, double-masked, 2-sequence × 2-period crossover study to evaluate ocular physiology following approximately one week of contact lens wear.

Conditions

Ocular Physiology

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1-Week Follow-up

Study Arms (2)

TEST/CONTROL

EXPERIMENTAL

Eligible subjects that are habitual contact lens wearers will be randomized into the (test/control) sequence and wear two different study lens designs (test and control designs) one at a time bilaterally over 2 wear periods.

Device: TEST LENS; Device: CONTROL LENS

CONTROL/TEST

EXPERIMENTAL

Eligible subjects that are habitual contact lens wearers will be randomized into the (control/test) sequence and wear two different study lens designs (test and control designs) one at a time bilaterally over 2 wear periods.

Device: TEST LENS; Device: CONTROL LENS

Interventions

TEST LENS DEVICE

AO1DfA manufactured with PG hydration

CONTROL/TEST; TEST/CONTROL

CONTROL LENS DEVICE

AO1DfA manufactured with IPA hydration

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 (inclusive) years of age at the time of screening.
• By self-report, habitually wear 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 2 days per week during the past month.
• Possess a wearable pair of spectacles that provide correction for distance vision.
• In both eyes, have astigmatic refractive error suitable for correction with the toric contact lens powers available in this study:
• Sphere powers (DS) -1.50 through -4.00 (inclusive) 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 submit 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 (6)

VRC

Jacksonville, Florida, 32256, United States

Location

Maitland Vision Center - North Orlando Ave

Maitland, Florida, 32751, United States

Location

Sacco Eye Group

Vestal, New York, 13850, 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: Ben 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: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: July 12, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 2, 2023
• Results First Posted: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

US (6)