A randomised controlled study on the effects of Mitomycin C versus placebo in adult endoscopic dacrocystorhinostomy

Phase 1

• Conditions: Watery or sticky eye due to blockage of tear ducts; MedDRA version: 9.1Level: LLTClassification code 10023622Term: Lacrimal duct obstruction; MedDRA version: 9.1Level: LLTClassification code 10023623Term: Lacrimal duct obstruction (acquired); MedDRA version: 9.1Level: LLTClassification code 10023634Term: Lacrimal mucocele

• Registration Number: EUCTR2007-001850-18-GB
• Lead Sponsor: HS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-16
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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

Pregnancy, lactation, serious concurrent illness, chronic, recurrent or clinically important infection, autoimmune disease

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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