NCT04149210

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,410 (actual)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Detailed description

The investigators are pursuing an agenda to evaluate a new potentially cost-effective approach to improving trichiasis surgery outcomes: perioperative topical anti-inflammatory therapy. Inflammation-whether induced by the trachoma disease process or surgery itself-most likely contributes to progressive cicatrization leading to failure of lid rotation surgery in a clinically important proportion of TT cases. The investigators hypothesize that adjunctive topical fluorometholone therapy following trichiasis surgery will reduce the risk of recurrent trichiasis and will be acceptably safe. The rationale for the efficacy aspect of this hypothesis is that interruption of inflammation postoperatively would reduce postoperative scarring/contracture driven by ongoing disease-driven inflammation and/or surgically-induced inflammation thus reducing the incidence of TT recurrence (post-operative TT) and other inflammation-related outcomes.

Conditions

• Trachomatous Trichiasis (TT)
• Eye Diseases
• Eyelid Diseases
• Trachomatous
• Trichiasis

Interventions

Type	Name	Description
DRUG	Fluorometholone 0.1% Oph Susp	fluorometholone 0.1% one drop twice daily for four weeks, beginning with one drop just before trachomatous trichiasis surgery on the upper lid.
DRUG	Artificial Tears	Artificial tears (placebo) given one drop twice daily for four weeks, beginning with one drop just prior to trachomatous trichiasis surgery on the upper lid.

Timeline

• Start date: 2021-08-19
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2019-11-04
• Last updated: 2026-03-24
• Results posted: 2026-03-24

Locations

1 site across 1 country: Ethiopia