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This is a 5-Visit, single-arm, single-site, subject masked, dispensing trial to evaluate contact lens discomfort and inflammatory biomarker expression.
The study will assess device feasibility for up to 10 habitual wearers of 4 different types of marketed contact lens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acuvue® Oasys 1-Day | Device | TEST Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Vision Care, Inc. Clinical Trial | Johnson & Johnson Vision Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Manchester | Manchester | M13 9PL | United Kingdom |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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The participant will be masked to the identity of the study lens even though only one arm has been specified.
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| 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 |
| up to 2-week follow-up |
| 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 |
| 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 |