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Determination of the Optimum Delivery Route for Botulinum Toxin A in Patients With Epiphora

NCT ID: NCT01282541

Last Updated: 2012-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-09-30

Brief Summary

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Epiphora or excessive tearing is a significant disability for many affected patients diminishing their quality of life. There is a growing consensus that injection of Botulinum Toxin A (BTX-A) into the lacrimal gland provides relief in patients with hyperlacrimation secondary to aberrant regeneration of the 7th nerve, and limited evidence that it might help to reduce normal tear production in patients with epiphora from anatomic or functional outflow obstructions. BTX-A has been injected both transconjunctivally into the palpebral lobe of the lacrimal gland and transcutaneously into the orbital lobe. Both delivery routes have been successful in symptom relief with minimal complications. However, the effectiveness of transconjunctival versus transcutaneous injections has not been systematically compared. Also, whether the incidence of side effects is related to the dosage, concentration, or location of injection is unknown and has also not been systematically studied. The investigators plan to conduct a randomized clinical trial in patients with functional tearing comparing the transcutaneous delivery route of BTX-A to the transconjunctival delivery route (the most common route described in the literature). The investigators will also compare the side effect profile of each delivery route.

Detailed Description

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Conditions

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Epiphora

Keywords

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Tearing, Epiphora, Botulinum Toxin A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Transconjunctival

Group Type ACTIVE_COMPARATOR

Botulinum Toxin Type A

Intervention Type DRUG

100 units/2ml 0.9% sodium chloride, 5 units delivered transconjunctivally into the palpebral lobe of the lacrimal gland once

Transcutaneous

Group Type ACTIVE_COMPARATOR

Botulinum Toxin Type A

Intervention Type DRUG

100 units/2ml 0.9% sodium chloride, 5 units delivered transcutaneously into the orbital lobe of the lacrimal gland once

Interventions

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Botulinum Toxin Type A

100 units/2ml 0.9% sodium chloride, 5 units delivered transconjunctivally into the palpebral lobe of the lacrimal gland once

Intervention Type DRUG

Botulinum Toxin Type A

100 units/2ml 0.9% sodium chloride, 5 units delivered transcutaneously into the orbital lobe of the lacrimal gland once

Intervention Type DRUG

Other Intervention Names

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Botox Botox

Eligibility Criteria

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Inclusion Criteria

* age over 18 years
* ability to give informed consent
* symptoms of epiphora in the setting of either a patent lacrimal outflow system or an obstructed outflow system for which the patient does not desire surgical therapy or is a poor surgical candidate

Exclusion Criteria

* pregnancy
* ocular motility abnormalities
* prior ptosis, and/or strabismus surgery
* more than 2 mm of pre-existing ptosis
* inability to give informed consent
* history of a bleeding disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merbs, Shannath, M.D., Ph.D.

INDIV

Sponsor Role lead

Responsible Party

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Shannath Merbs, M.D., Ph.D.

Associate Professor of Ophthalmology and Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shannath Merbs, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Wilmer Eye Institute

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00025405

Identifier Type: -

Identifier Source: org_study_id