Bupivacaine Epiphora Trial NCT03266081

Updated 05/17/2024

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number	NCT03266081
Other study ID #	HS#: 14-00614
Secondary ID
Status	Withdrawn
Phase	Phase 2
First received
Last updated
Start date	April 2015
Est. completion date	August 23, 2022

Study information
Verified date	August 2022
Source	McMaster University
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status	Withdrawn
Enrollment	0
Est. completion date	August 23, 2022
Est. primary completion date	August 23, 2022
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	18 Years and older
Eligibility	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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 0.75% bupivacaine
topical anesthetic

Locations
Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors *(1)*
Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	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	measurements at baseline and 6 months
Secondary	Change from baseline Lid distraction at 6 months	distance (in mm) that the eyelids can be maximally pulled from the globe	measurements at baseline and 6 months
Secondary	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	measurements at baseline and 6 months

See also
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	Completed	`NCT02240615` - The Sinopsys Lacrimal Stent for Lacrimal System Repair in Epiphora	Phase 0
	Suspended	`NCT03705000` - SLlt Stent II Lacrimal Stent for the Treatment of Nasolacrimal Duct Obstruction	N/A
	Completed	`NCT01010659` - The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora	Phase 4
	Recruiting	`NCT05663684` - Does Topical Ophthalmic Proparacaine 0.5% Prior to Probing and Irrigation Decrease Pain?	Phase 4
	Terminated	`NCT04229771` - Does Topical Ophthalmic Anesthetic Prior to Probing and Irrigation Decrease Pain?	Phase 4
	Active, not recruiting	`NCT02849093` - Optical Coherence Tomography of Ocular Structures in Epiphora and Dry Eye Syndrome.	N/A
	Withdrawn	`NCT00824811` - Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel	Phase 2
	Completed	`NCT00266838` - Prevention of Docetaxel Induced Dacryostenosis	Phase 1
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	Active, not recruiting	`NCT04680078` - Placement of Three Interrupted Sutures After Triangular Three-snip Punctoplasty	N/A
	Completed	`NCT01282541` - Determination of the Optimum Delivery Route for Botulinum Toxin A in Patients With Epiphora	Phase 2
	Completed	`NCT02503956` - Perforated Punctal Plugs for Treatment of Papillary Conjunctivitis in Otherwise Healthy Patients	N/A
	Completed	`NCT04637633` - Topical Cyclosporine-A for Management of Epiphora	Phase 2/Phase 3
	Completed	`NCT01766232` - Lacrimal Drainage Resistance Study	N/A