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

Phase 2

Completed

• Conditions: Epiphora
• Interventions: Drug: Botulinum Toxin Type A

• Registration Number: NCT01282541
• Lead Sponsor: Merbs, Shannath, M.D., Ph.D.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-21
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Study Start: 2011-02
• Status Verified: 2012-09
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-11
• Last Update Posted: 2012-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transconjunctival	Botulinum Toxin Type A	-
Transcutaneous	Botulinum Toxin Type A	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Wilmer Eye Institute; 🇺🇸 Baltimore, Maryland, United States