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

Treatment of functional EPIFORA with Botulinum Toxin versus lateral tarsal strip

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000740-34-ES

Enrollment

Registered

2017-05-29

Start date

2017-09-28

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Epifora

Interventions

Trade Name: Xeomin® Product Name: IncobotulinumtoxinA Product Code: IncobotulinumtoxinA Pharmaceutical Form: Powder and solution for solution for inject

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 6 weeks after treatment;Main Objective: Compare through the Munk Scale the efficacy of Botulinum Toxin A (IncobotulinuntoxinA) versus lateral tarsal strip, which is the usual surgery technique to treat the functional epifora, after 6 weeks of treatment.; Secondary Objective: Compare through the Schirmer Test the efficacy of treatment with Botulinum Toxin A VS lateral tarsal strip, the usual surgery technique, to treat the functional epifora after 2, 6, 12, 18, 24 and 30 weeks and through the Munk Scale after 2, 12, 18, 24 and 30 weeks . Evaluate the effect duration of Botulinum Toxin A in functional epifora. Describe the adverse events of Botulinum Toxin A. Assess the relationship between the Munk Scale and the Shirmer Test in functional epífora. *Evaluate the successful rate in both treatments according to the laxity palpebral grade through the palpebral traction technique. ;Primary end point(s): Munk Scale	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 6 weeks after treatment;Main Objective: Compare through the Munk Scale the efficacy of Botulinum Toxin A (IncobotulinuntoxinA) versus lateral tarsal strip, which is the usual surgery technique to treat the functional epifora, after 6 weeks of treatment.; Secondary Objective: *Compare through the Schirmer Test the efficacy of treatment with Botulinum Toxin A VS lateral tarsal strip, the usual surgery technique, to treat the functional epifora after 2, 6, 12, 18, 24 and 30 weeks and through the Munk Scale after 2, 12, 18, 24 and 30 weeks . *Evaluate the effect duration of Botulinum Toxin A in functional epifora. *Describe the adverse events of Botulinum Toxin A. *Assess the relationship between the Munk Scale and the Shirmer Test in functional epífora. *Evaluate the successful rate in both treatments according to the laxity palpebral grade through the palpebral traction technique. ;Primary end point(s): Munk Scale

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Schimer Test: 2, 6, 12, 18, 24 and 30 weeks after treatment. Munk Scale: 2, 12, 18, 24 and 30 weeks after treatment. Shin et al. questionnaire: before and after both treatments. Palpebral traction technique: not defined. ; Secondary end point(s): Schimer Test. Munk Scale Shin et al. questionnaire. Palpebral traction technique.	—

Countries

Spain

Contacts

Public ContactBorja Maroto

Dr. Borja Maroto Rodríguez

bormar77@yahoo.es

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026