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| Name | Class |
|---|---|
| University of Waterloo School of Optometry and Vision Science | UNKNOWN |
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The objective of the study is to evaluate the short-term change in choroidal thickness induced by 3 prototype soft contact lenses for people with myopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens A | Experimental |
| |
| Lens B | Experimental |
| |
| Lens C | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lens A | Device | Lens A of Study P/883/24/MO |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Choroidal Thickness from Baseline to After 1 Hour of Contact Lens Wear | The change in sub-foveal choroidal thickness for the 3 study contact lenses will be compared from baseline to after 1 hour of contact lens wear. Measurements will be conducted on the right eye using a swept-source Optical Coherence Tomographer and measured in micrometers. | After 1 hour of wearing each contact lens |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Ocular Research and Education at the School of Optometry and Vision Science at Waterloo University | Recruiting | Waterloo | Ontario | N2L 3G1 | Canada |
The results are regarded as confidential to our business as Sponsor, and confidential for the selection of one device to use in a future efficacy trial. There are no plans for a public data repository for this study.
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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We understand that this falls outside the realm of a feasibility study given the intended sample size of 20 subjects. That being stated we selected Other in our resubmission, because in our opinion none of the "Primary Purpose" selection options fit the intent of studying the contact lenses impact on the choroid to detect the eyes' ability to respond to the defocus created by these lenses. These data will help inform further development decisions for an eventual clinical trial.
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| Lens B |
| Device |
Lens B of Study P/883/24/MO |
|
| Lens C | Device | Lens C of Study P/883/24/MO |
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