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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
60
40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 10 mm length
40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 20 mm length
Mean Retention Time
At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.
Time frame: From baseline (Day 0) up to Month 3
Percentage of Subjects Retaining the Stent at Month 3
At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.
Time frame: Month 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.