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Bupivacaine Epiphora Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03266081
Recruitment Status : Suspended (Moved to complete)
First Posted : August 29, 2017
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Albert Wu, Stanford 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.

Condition or disease Intervention/treatment Phase
Epiphora Ptosis Drug: 0.75% bupivacaine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 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 : April 2015
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: 0.75% bupivacaine Drug: 0.75% bupivacaine
topical anesthetic




Primary Outcome Measures :
  1. Change from Baseline Lacrimal Tear Lake at 6 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266081


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Albert Y Wu, MD PhD Icahn School of Medicine at Mount Sinai
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Responsible Party: Albert Wu, Assistant Professor, Ophthalmology, Stanford University
ClinicalTrials.gov Identifier: NCT03266081    
Other Study ID Numbers: HS#: 14-00614
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lacrimal Apparatus Diseases
Eye Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents