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Clinical trialNCT04149210CompletedPhase 3Interventional

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

SponsorMassachusetts Eye and Ear InfirmaryEnrollment2,410Eye DiseasesEyelid DiseasesTrachomatousTrachomatous Trichiasis (TT)Trichiasis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Ethiopia
  • Oromia Health Bureau

    Addis Ababa, Addis Ababa, Ethiopia

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Artificial TearsFluorometholone 0.1% Oph Susp
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
19 Aug 2021
Primary completion
30 Nov 2024
Completion
30 Nov 2024
Last update posted
24 Mar 2026
Registered enrollment
2,410
Registry id
NCT04149210
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.