Non-Significant Risk Feasibility Study to Assess Retention and Replacement of the OTX Punctum Plug
This trial is active, not recruiting.
|Sponsor||Ocular Therapeutix, Inc.|
|Start date||February 2013|
|End date||December 2016|
|Trial size||60 participants|
|Trial identifier||NCT01800175, OTX-13-001|
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.
|Endpoint classification||safety study|
|Intervention model||parallel assignment|
Punctum Plug retention for 90 days post insertion
time frame: 360 days
Successful insertion of a replacement OTX Punctum Plug at Days 90, 180 and 270
time frame: 270 days
Male or female participants at least 40 years old.
Inclusion Criteria: - Subject must be greater than or equal to 40 years of age. - Subject is in general good health with overall healthy eyes. - Subject has been informed of the nature of the study and is able to comply with study requirements, the visit schedule and has provided written informed consent, approved by the appropriate IRB. Exclusion Criteria: - Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis). - History of ocular trauma within the past 6 months in either eye. - History of ocular infection (bacterial, viral, or fungal) or ocular inflammation within 3 months prior to the study in either eye. - History of chronic or recurrent inflammatory eye disease (i.e., iritis, scleritis, uveitis, herpes keratitis) in either eye. - History of clinically relevant or progressive retinal diseases such as retinal detachment, retinal degeneration, or diabetic retinopathy in either eye. - History of any other severe ocular pathology (including severe dry eye) in either eye. - History of any laser or incisional surgery within 6 weeks prior to the study or scheduled ocular surgery during the study.
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