Bupivacaine Epiphora Trial

• Sponsor: McMaster University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03266081
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Actual Duration (Months): 88.7
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Epiphora; Ptosis	Drug: 0.75% bupivacaine	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improving Epiphora & Ptosis With Bupivacaine
• Actual Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Aug 23, 2022
• Actual Study Completion Date: Aug 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.75% bupivacaine	Drug: 0.75% bupivacaine; topical anesthetic

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• McMaster University

Investigators

• Principal Investigator: Albert Y Wu, MD PhD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Albert Wu, Assistant Professor, Ophthalmology, Stanford University
• ClinicalTrials.gov Identifier: NCT03266081
• Other Study ID Numbers: HS#: 14-00614
• First Posted: Aug 29, 2017
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lacrimal Apparatus Diseases; Bupivacaine

Study Results

No Results Posted as of Aug 25, 2022