Back to resultsPunctal Plug Study to Determine the Safety and Retention Times of Various Lengths of Canalicular Stents in Volunteers
Primary Purpose
Healthy, Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MINI MONOKA canalicular stent, 10 mm
MINI MONOKA canalicular stent, 20 mm
Sponsored by
About this trial
This is an interventional screening trial for Healthy focused on measuring Dry eye, Tear duct, Punctal plug
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Canalicular stent, 10 mm
Canalicular stent, 20 mm
Arm Description
MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
Outcomes
Primary Outcome Measures
Mean Retention Time
At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00743249
Brief Title
Punctal Plug Study to Determine the Safety and Retention Times of Various Lengths of Canalicular Stents in Volunteers
Official Title
A Three-Month Safety Study to Determine the Retention Times of Side-Arm Canalicular Stents
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Dry Eye
Keywords
Dry eye, Tear duct, Punctal plug
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Canalicular stent, 10 mm
Arm Type
Experimental
Arm Description
MINI MONOKA canalicular stent (tube), 10 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
Arm Title
Canalicular stent, 20 mm
Arm Type
Experimental
Arm Description
MINI MONOKA canalicular stent (tube), 20 mm, inserted in the lower lacrimal canaliculus (tear duct) of one eye for up to 3 months
Intervention Type
Device
Intervention Name(s)
MINI MONOKA canalicular stent, 10 mm
Other Intervention Name(s)
MINI MONOKA
Intervention Description
40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 10 mm length
Intervention Type
Device
Intervention Name(s)
MINI MONOKA canalicular stent, 20 mm
Other Intervention Name(s)
MINI MONOKA
Intervention Description
40 mm hollow intubation stent composed of a silicon tube and an oval collarette head (plug), cut to 20 mm length
Primary Outcome Measure Information:
Title
Mean Retention Time
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Subjects Retaining the Stent at Month 3
Description
At all study visits the investigator conducted a slit lamp examination to determine whether the canalicular stent was present.
Time Frame
Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa A Landry, Ph.D.
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Punctal Plug Study to Determine the Safety and Retention Times of Various Lengths of Canalicular Stents in Volunteers
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