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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shannath Merbs, M.D., Ph.D., Merbs, Shannath, M.D., Ph.D.
ClinicalTrials.gov Identifier:
NCT01282541
First received: January 21, 2011
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Epiphora
Drug: Botulinum Toxin Type A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determination of the Optimum Delivery Route for the Intraglandular Administration of Botulinum Toxin A in Patients With Refractory Epiphora

Resource links provided by NLM:


Further study details as provided by Merbs, Shannath, M.D., Ph.D.:

Primary Outcome Measures:
  • Comparison of 1-minute Schirmer's test with and without anesthesia between treatment groups at baseline and follow up [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of side effect between each treatment group [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Comparison of average score on epiphora severity scale between groups of interest at baseline and follow-up [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: February 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transconjunctival Drug: Botulinum Toxin Type A
100 units/2ml 0.9% sodium chloride, 5 units delivered transconjunctivally into the palpebral lobe of the lacrimal gland once
Other Name: Botox
Active Comparator: Transcutaneous 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
Other Name: Botox

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01282541

Locations
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Merbs, Shannath, M.D., Ph.D.
Investigators
Principal Investigator: Shannath Merbs, MD, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Shannath Merbs, M.D., Ph.D., Associate Professor of Ophthalmology and Oncology, Merbs, Shannath, M.D., Ph.D.
ClinicalTrials.gov Identifier: NCT01282541     History of Changes
Other Study ID Numbers: NA_00025405
Study First Received: January 21, 2011
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merbs, Shannath, M.D., Ph.D.:
Tearing, Epiphora, Botulinum Toxin A

Additional relevant MeSH terms:
Lacrimal Apparatus Diseases
Eye Diseases
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014