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

Epiphora Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282541
• Other study ID #: NA_00025405
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2011
• Last updated: September 11, 2012
• Start date: February 2011
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Merbs, Shannath, M.D., Ph.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epiphora

Intervention

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
• Botulinum Toxin Type A
100 units/2ml 0.9% sodium chloride, 5 units delivered transcutaneously into the orbital lobe of the lacrimal gland once

Locations

Country	Name	City	State
United States	Wilmer Eye Institute	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Merbs, Shannath, M.D., Ph.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of 1-minute Schirmer's test with and without anesthesia between treatment groups at baseline and follow up		24 weeks	No
Secondary	Comparison of side effect between each treatment group		24 weeks	Yes
Secondary	Comparison of average score on epiphora severity scale between groups of interest at baseline and follow-up		24 weeks	No