Changes in Inflammatory Biomarkers When Symptomatic Contact Lens Wearers Are Refit in Acuvue Oasys 1-Day Lenses

NCT05120128 | Completed FDA Device

• 1 other identifier: CR-6433
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 5-Visit, single-arm, single-site, subject masked, dispensing trial to evaluate contact lens discomfort and inflammatory biomarker expression.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (6)

• CLDEQ-8 Score follow up 1

  Correlation between change in CLDEQ-8 score and change in MMP-9 biomarker expression

  at 1-week follow-up

• CLDEQ-8 Score follow up 2

  Correlation between change in CLDEQ-8 score and change in MMP-9 biomarker expression

  at 2-week follow-up

• MMP-9 Expression in Epithelial Cells of Bulbar Conjunctiva

  Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the temporal bulbar conjunctiva in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response.

  at 1-week follow-up

• MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper

  Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the upper lid margin in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response.

  at 1-week follow-up

• MMP-9 Expression in Epithelial Cells of Bulbar Conjunctiva

  Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the temporal bulbar conjunctiva in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response.

  at 2-week follow-up

• MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper

  Each subject will have EyeprimTM samples collected which involves the 'double impression' technique where samples are collected twice from the same location using a single EyeprimTM membrane. Samples will be collected from the upper lid margin in both eyes. From these samples, biomarker expression for MMP-9 will be measured. A higher level of MMP-9 expression is associated with a stronger inflammatory response.

  at 2-week follow-up

Secondary Outcomes (3)

• Average difference in CLDEQ-8 scores between Subjects' own lens and AO1D

  up to 2-week follow-up

• Average Difference in MMP-9 Expression in Epithelial Cells of Bulbar Conjuctiva between Subjects' own lens and AO1D

  up to 2 week follow up

• Average Difference in MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper between Subjects' own lens and AO1D

  up to 2 week follow up

Study Arms (1)

TEST Lens

EXPERIMENTAL

Eligible subjects who are habitual soft contact lens wearers will enter wearing their own lens, then given the TEST Lens for the remainder of the study.

Device: Acuvue® Oasys 1-Day

Interventions

Acuvue® Oasys 1-Day DEVICE

TEST Lens

TEST Lens

Eligibility Criteria

• Age: 18 Years - 60 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 60 (inclusive) years of age at the time of screening.
• By self-report, habitually wear one of four soft spherical contact lens types (1-Day Acuvue Moist, Dailies Aqua Comfort Plus, Dailies Total1, Clariti 1 Day) in both eyes in a daily disposable wear modality. Habitual wear is defined as a minimum of 8 hours of wear per day, for a minimum of 4 days per week during the past 4 weeks.
• Have a CLDEQ-8 score at pre-screening of 15 or more.
• Own a wearable pair of spectacles.
• The habitual contact lens sphere correction in each eye must be between -6.00 and -0.50 D or between +0.50 and +4.00 D (inclusive).
• The magnitude of the cylinder component of the subject's distance over-refraction must be 1.00 DC or less in each eye.
• The subject must have visual acuity of 0.2 high contrast logMAR or better with spherocylinder over-refraction 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 breastfeeding
• 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 had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract etc.).
• Habitually wear multi-focal, toric, or extended wear contact lens correction
• Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
• Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
• Have a history of amblyopia or strabismus.
• Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (eg. SynergEyes) within the past 6 months.
• Have clinically significant (grade 3 or higher on the Efron grading scale) slit lamp findings (e.g., corneal edema or neovascularization, conjunctival or limbal redness) or any other abnormality which would normally contraindicate contact lens wear
• Have any ocular infection.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The participant will be masked to the identity of the study lens even though only one arm has been specified.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: November 24, 2021
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)