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

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

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.

Study Overview

• Status: Completed
• Conditions: Epiphora
• Intervention / Treatment: Drug: Botulinum Toxin Type A; Drug: Botulinum Toxin Type A

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Wilmer Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Botox; 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 Names: Botox
Active Comparator: Transcutaneous	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 Names: Botox; 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 Names: Botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of 1-minute Schirmer's test with and without anesthesia between treatment groups at baseline and follow up	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Comparison of side effect between each treatment group	24 weeks
Comparison of average score on epiphora severity scale between groups of interest at baseline and follow-up	24 weeks

Collaborators and Investigators

• Sponsor: Merbs, Shannath, M.D., Ph.D.
• Investigators: Principal Investigator: Shannath Merbs, MD, PhD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: January 21, 2011
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Estimate): September 12, 2012
• Last Update Submitted That Met QC Criteria: September 11, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Tearing, Epiphora, Botulinum Toxin A
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: NA_00025405