Watery or sticky eye due to blockage of tear ducts MedDRA version: 9.1 Level: LLT Classification code 10023622 Term: Lacrimal duct obstruction MedDRA version: 9.1 Level: LLT Classification code 10023623 Term: Lacrimal duct obstruction (acquired) MedDRA version: 9.1 Level: LLT Classification code 10023634 Term: Lacrimal mucocele
Conditions
Interventions
Trade Name: Mitomycin C
Product Name: Mitomycin C
Pharmaceutical Form: Powder for injection*
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Topical
Sponsors
NHS Tayside
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing endoscopic dacrocystorhinostomy for epiphora 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy, lactation, serious concurrent illness, chronic, recurrent or clinically important infection, autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine efficacy of Mitomycin C in improving outcome following dacrocystorhinostomy for lacrimal duct obstruction. Main endpoints will be change in visual analogue scale and fluorescein appearance / disappearance tests.;Secondary Objective: ;Primary end point(s): Patency of fistula, reduction of symptoms | — |
Countries
United Kingdom
Outcome results
None listed