A Three-Month Safety Study to Determine the Retention Times of Side-Arm Canalicular Stents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 60
- Primary Endpoint
- Mean Retention Time
Study Overview
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 in subjects with or without dry eye.
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 at the Day 2 visit. If the stent insertion was not successfully completed by the end of the Day 2 visit, the subject was discontinued from the study. Any subject who had the stent inserted but lost the stent (noticed or unnoticed) after the Day 2 Visit was considered to have completed the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Mean Retention Time
Time Frame: From baseline (Day 0) up to Month 3
At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.
Secondary Outcomes
- Percentage of Subjects Retaining the Stent at Month 3(Month 3)