Back to resultsBupivacaine Epiphora Trial
Primary Purpose
Epiphora, Ptosis
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.75% bupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Epiphora
Eligibility Criteria
Inclusion Criteria:
Patients age 18 and above, patients with unilateral or bilateral excessive tearing.
Exclusion Criteria:
Pregnant females, vulnerable populations, patients with severe hepatic disease, or patients using monoamine oxidase inhibitors or tricyclic antidepressants, which are contraindicated with bupivacaine and norepinephrine combinations.
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
0.75% bupivacaine
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline Lacrimal Tear Lake at 6 months
Measurement of the height (in mm) of the tear film in the lower conjunctival cup de sac, obtained during slit lamp examination of the eye
Secondary Outcome Measures
Change from baseline Lid distraction at 6 months
distance (in mm) that the eyelids can be maximally pulled from the globe
Change from baseline Lid snap back at 6 months
Amount of time (in sec) it takes for the lids to return to their normal anatomical position after being pulled to their maximum excursion with fingers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03266081
Brief Title
Bupivacaine Epiphora Trial
Official Title
Improving Epiphora & Ptosis With Bupivacaine
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No patients
Study Start Date
April 2015 (Actual)
Primary Completion Date
August 23, 2022 (Actual)
Study Completion Date
August 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The objective of this study is to investigate quantitative improvement in excessive tearing after administration of Bupivacaine, a local anesthetic, into the affected eyelids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiphora, Ptosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.75% bupivacaine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
0.75% bupivacaine
Intervention Description
topical anesthetic
Primary Outcome Measure Information:
Title
Change from Baseline Lacrimal Tear Lake at 6 months
Description
Measurement of the height (in mm) of the tear film in the lower conjunctival cup de sac, obtained during slit lamp examination of the eye
Time Frame
measurements at baseline and 6 months
Secondary Outcome Measure Information:
Title
Change from baseline Lid distraction at 6 months
Description
distance (in mm) that the eyelids can be maximally pulled from the globe
Time Frame
measurements at baseline and 6 months
Title
Change from baseline Lid snap back at 6 months
Description
Amount of time (in sec) it takes for the lids to return to their normal anatomical position after being pulled to their maximum excursion with fingers
Time Frame
measurements at baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients age 18 and above, patients with unilateral or bilateral excessive tearing.
Exclusion Criteria:
Pregnant females, vulnerable populations, patients with severe hepatic disease, or patients using monoamine oxidase inhibitors or tricyclic antidepressants, which are contraindicated with bupivacaine and norepinephrine combinations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Y Wu, MD PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bupivacaine Epiphora Trial
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