Status:
COMPLETED
Punctal Plug Study to Determine the Safety and Retention Times of Various Lengths of Canalicular Stents in Volunteers
Lead Sponsor:
Alcon Research
Conditions:
Healthy
Dry Eye
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
The purpose of this study was to determine the safety and retention times of two different lengths (10 mm and 20 mm) of the MINI MONOKA canicular stent when inserted in the eye for up to three months ...
Detailed Description
This study consisted of 6 visits conducted over a period of 3 months. At Visit 1 (Day 0), the canalicular stent was inserted. If the stent insertion failed, the subject was rescheduled for insertion a...
Eligibility Criteria
Inclusion
- Sign Informed Consent.
- With or without dry eye.
- Willing to discontinue contact lenses during the study.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Chronic, recurrent, or severe inflammatory eye disease.
- Ocular trauma within the past 6 months.
- Ocular hypertension or glaucoma.
- History of punctal plug/canalicular stent insertion.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00743249
Start Date
October 1 2008
End Date
February 1 2009
Last Update
April 4 2013
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