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OpenTrials
Completed

NCT Number: NCT01282541

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Botox

Primary outcomes

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

    Time frame: 24 weeks

Secondary outcomes

  1. Comparison of side effect between each treatment group

    Time frame: 24 weeks

  2. Comparison of average score on epiphora severity scale between groups of interest at baseline and follow-up

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

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

Indiv

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 25, 2011
Registry last updated
Sep 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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