NCT03266081

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

7.4 years

First QC Date

August 22, 2017

Last Update Submit

August 23, 2022

Conditions

EpiphoraPtosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from baseline Lid distraction at 6 months

    measurements at baseline and 6 months

  • Change from baseline Lid snap back at 6 months

    measurements at baseline and 6 months

Study Arms (1)

0.75% bupivacaine

EXPERIMENTAL
Drug: 0.75% bupivacaine

Interventions

0.75% bupivacaineDRUG

topical anesthetic

0.75% bupivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Lacrimal Apparatus DiseasesBlepharoptosis

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Eye DiseasesEyelid Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Albert Y Wu, MD PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Ophthalmology

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 29, 2017

Study Start

April 1, 2015

Primary Completion

August 23, 2022

Study Completion

August 23, 2022

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)