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

NCT ID: NCT05120128

Last Updated: 2023-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-24
• Study Completion Date: 2022-12-13

Brief Summary

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

Detailed Description

The study will assess device feasibility for up to 10 habitual wearers of 4 different types of marketed contact lens.

Conditions

Visual Acuity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

TEST Lens

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.

Group Type: EXPERIMENTAL

Acuvue® Oasys 1-Day

Intervention Type: DEVICE

TEST Lens

Interventions

Acuvue® Oasys 1-Day

TEST Lens

Intervention Type: DEVICE

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 60 (inclusive) years of age at the time of screening.

4. 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.

5. Have a CLDEQ-8 score at pre-screening of 15 or more.

6. Own a wearable pair of spectacles.

7. 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).

8. The magnitude of the cylinder component of the subject's distance over-refraction must be 1.00 DC or less in each eye.

9. The subject must have visual acuity of 0.2 high contrast logMAR or better with spherocylinder over-refraction 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 breastfeeding

2. 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.

3. Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract etc.).

4. Habitually wear multi-focal, toric, or extended wear contact lens correction

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

6. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)

7. Have a history of amblyopia or strabismus.

8. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (eg. SynergEyes) within the past 6 months.

9. 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

10. Have any ocular infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 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

The University of Manchester

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

CR-6433

Identifier Type: -

Identifier Source: org_study_id