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

Primary Purpose

Epiphora

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Botulinum Toxin Type A
Sponsored by
Merbs, Shannath, M.D., Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epiphora focused on measuring Tearing, Epiphora, Botulinum Toxin A

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wilmer Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transconjunctival

Transcutaneous

Arm Description

Outcomes

Primary Outcome Measures

Comparison of 1-minute Schirmer's test with and without anesthesia between treatment groups at baseline and follow up

Secondary Outcome Measures

Comparison of side effect between each treatment group
Comparison of average score on epiphora severity scale between groups of interest at baseline and follow-up

Full Information

First Posted
January 21, 2011
Last Updated
September 11, 2012
Sponsor
Merbs, Shannath, M.D., Ph.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01282541
Brief Title
Determination of the Optimum Delivery Route for Botulinum Toxin A in Patients With Epiphora
Official Title
Determination of the Optimum Delivery Route for the Intraglandular Administration of Botulinum Toxin A in Patients With Refractory Epiphora
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Merbs, Shannath, M.D., Ph.D.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiphora
Keywords
Tearing, Epiphora, Botulinum Toxin A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transconjunctival
Arm Type
Active Comparator
Arm Title
Transcutaneous
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Botox
Intervention Description
100 units/2ml 0.9% sodium chloride, 5 units delivered transconjunctivally into the palpebral lobe of the lacrimal gland once
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Botox
Intervention Description
100 units/2ml 0.9% sodium chloride, 5 units delivered transcutaneously into the orbital lobe of the lacrimal gland once
Primary Outcome Measure Information:
Title
Comparison of 1-minute Schirmer's test with and without anesthesia between treatment groups at baseline and follow up
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Comparison of side effect between each treatment group
Time Frame
24 weeks
Title
Comparison of average score on epiphora severity scale between groups of interest at baseline and follow-up
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannath Merbs, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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