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

NCT01282541 | Completed Phase 2 DMC

• 1 other identifier: NA_00025405
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Epiphora

Keywords

Tearing, Epiphora, Botulinum Toxin A

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

Transconjunctival

ACTIVE COMPARATOR

Drug: Botulinum Toxin Type A

Transcutaneous

ACTIVE COMPARATOR

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A DRUG

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

Also known as: Botox

Transconjunctival

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merbs, Shannath, M.D., Ph.D.: lead

Study Sites (1)

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Lacrimal Apparatus Diseases; Lacerations

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Eye Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Shannath Merbs, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology and Oncology

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 25, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 12, 2012

Record last verified: 2012-09

Locations

US (1)