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The purpose of this study is to evaluate retention and replacement of the OTX Punctum Plug when placed in the canaliculus of the eyelid. Subjects will be followed for up to 1 year in order to assess retention and replacement of the OTX Punctum Plug for this duration. At the Day 90 visit, subjects will receive a second OTX Punctum Plug after removal of the initial OTX Punctum Plug. The subject will return for visits at Day 180, 270 and 360. On Days 180 and 270, the subject will again receive a new OTX Punctum Plug after the previous OTX Punctum Plug is removed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation C | Experimental | Two formulations of the OTX Punctum Plug will be evaluated in this trial. The difference in formulations is the time required for degradation of the PEG hydrogel. The persistence of OTX Punctum Plug (Formulation C) is anticipated to be slightly shorter than the persistence of OTX Punctum Plug (Formulation D). |
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| Formulation D | Experimental | Two formulations of the OTX Punctum Plug will be evaluated in this trial. The difference in formulations is the time required for degradation of the PEG hydrogel. The persistence of OTX Punctum Plug (Formulation C) is anticipated to be slightly shorter than the persistence of OTX Punctum Plug (Formulation D). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Punctum Plug | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Punctum Plug retention for 90 days post insertion | Retention of the first OTX Punctum Plug through Day 90, retention of the second OTX Punctum Plug through Day 180, retention of the third OTX Punctum Plug through Day 270, retention of the fourth OTX Punctum Plug through Day 360 | 360 days |
| Measure | Description | Time Frame |
|---|---|---|
| Successful insertion of a replacement OTX Punctum Plug at Days 90, 180 and 270 | 270 days |
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Inclusion Criteria:
Exclusion Criteria:
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