Treatment of continuous tearing with Botulinum Toxin versus the inferior eyelid tightening technique

Phase 1

• Conditions: Functional Epifora; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-000740-34-ES
• Lead Sponsor: Dr. Borja Maroto Rodríguez

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-29
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

*Patients older than 18 years
*Epifora with permeable tear duct with at least grade 3 in the Munk Scale.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

*Pregnancy and Breastfeeding.
*Patients with blepharoconjunctivitis with or without keratitis.
*Palpebral malposition.
*Background of previous palpebral surgery.
*Tear Dysfunction Syndrome.
*History of eye trauma or the tear duct.
*Previous dacryocystorhinostomy.
*Background of previous refractive surgery.
*Coagulopathy.
*Ptosis.
*Disfunction of eye motility.
*Hypersensitivity to Botulinum Toxin A or to any of the product excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified