N/A
Completed N=60
Punctal Plug Study to Determine the Safety and Retention Times of Various Lengths of Canalicular Stents in Volunteers
Healthy · Dry Eye Disease
Source: ClinicalTrials.gov NCT00743249 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcomePrimary: Mean Retention Time — 87.4; 61.9 Days
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 in subjects with or without dry eye.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Retention Time |
87.4; 61.9 | — |
| SECONDARY Percentage of Subjects Retaining the Stent at Month 3 |
92.9; 48.3 | — |
Eligibility Criteria
Inclusion Criteria
- Sign Informed Consent.
- With or without dry eye.
- Willing to discontinue contact lenses during the study.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00743249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.