Bupivacaine Epiphora Trial

Phase 2

Withdrawn

• Conditions: Epiphora; Ptosis
• Interventions: Drug: 0.75% bupivacaine

• Registration Number: NCT03266081
• Lead Sponsor: McMaster University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-29
• Status Verified: 2022-08
• Primary Completion: 2022-08-23
• Study Completion: 2022-08-23
• Last Update Submitted: 2022-08-23
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients age 18 and above, patients with unilateral or bilateral excessive tearing.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
0.75% bupivacaine	0.75% bupivacaine	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline Lacrimal Tear Lake at 6 months	measurements at baseline and 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

Name	Time	Method
Change from baseline Lid distraction at 6 months	measurements at baseline and 6 months	distance (in mm) that the eyelids can be maximally pulled from the globe
Change from baseline Lid snap back at 6 months	measurements at baseline and 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

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States