Status:
UNKNOWN
Non-Significant Risk Feasibility Study to Assess Retention and Replacement of the OTX Punctum Plug
Lead Sponsor:
Ocular Therapeutix, Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01800175
Start Date
February 1 2013
Last Update
February 11 2016
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