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

Visual Acuity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05120128
• Other study ID #: CR-6433
• Status: Completed
• Phase: N/A
• Start date: November 24, 2021
• Est. completion date: December 13, 2022

Study information

• Verified date: November 2023
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 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 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.

Related Conditions & MeSH terms

• Visual Acuity

Intervention

Device:
• Acuvue® Oasys 1-Day
TEST Lens

Locations

Country	Name	City	State
United Kingdom	The University of Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Average difference in CLDEQ-8 scores between Subjects' own lens and AO1D	CLDEQ-8 is a validated outcome measure for soft contact lens wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses.10 The sum of the item scores of CLDEQ-8, ranging from 0 to 37, will be used to assess dry eye symptoms, where higher scores indicated more serious symptoms. The score will be calculated for each group (subject's own lens and AO1D) and timepoint (1- and 2-week follow-up). The difference between subjects' own lens and AO1D will be calculated as (AO1D minus subjects' own lens). The average will be reported for each timepoint.	up to 2-week follow-up
Secondary	Average Difference in MMP-9 Expression in Epithelial Cells of Bulbar Conjuctiva between Subjects' own lens and AO1D	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 conjuctiva 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. The score will be measured for each group (subject's own lens and AO1D) and timepoint (1- and 2-week follow-up). The difference between subjects' own lens and AO1D will be measured as (AO1D minus subjects' own lens). The average difference will be reported for each timepoint.	up to 2 week follow up
Secondary	Average Difference in MMP-9 Expression in Epithelial Cells of Upper Eyelid Wiper between Subjects' own lens and AO1D	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. The score will be measured for each group (subject's own lens and AO1D) and timepoint (1- and 2-week follow-up). The difference between subjects' own lens and AO1D will be measured as (AO1D minus subjects' own lens). The average difference will be reported for each timepoint.	up to 2 week follow up