Overview

FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial

Status:
Recruiting
Trial end date:
2024-08-31
Target enrollment:
Participant gender:
Summary
This study aims : - To assess the efficacy of fluorometholone 0.1% one drop twice daily for four weeks in reducing the incidence of post-operative trachomatous trichiasis (TT) when given as adjunctive therapy with TT surgery in the programmatic setting - To assess whether such treatment is sufficiently safe for wide-scale implementation in TT programs. - To estimate the costs of adding fluorometholone 0.1% treatment to TT surgery per case of postoperative TT averted, and to characterize the value of such treatment under a range of plausible health economic circumstances
Phase:
Phase 3
Details
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Collaborators:
Berhan Public Health and Eye Care Consultancy
Berhan Public Health and Eye Care Consultancy PLC
Fred Hollows Foundation
London School of Hygiene and Tropical Medicine
The Fred Hollows Foundation, Australia
The Fred Hollows Foundation, Ethiopia
University of Pennsylvania
Treatments:
Fluorometholone
Lubricant Eye Drops