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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
34
TEST Lens
The University of Manchester
Manchester, United Kingdom
CLDEQ-8 Score follow up 1
Correlation between change in CLDEQ-8 score and change in MMP-9 biomarker expression
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at 2-week follow-up
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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.
Time frame: at 2-week follow-up
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.
Time frame: 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.
Time frame: 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.
Time frame: up to 2 week follow up