CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,410 enrolled
Drug / intervention
Fluorometholone 0.1% Oph Susp +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04149210
NCT04149210Phase 3Completed
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FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial

Massachusetts Eye and Ear Infirmary·interventional·Posted Nov 4, 2019·Updated Mar 24, 2026

In Brief

A Phase 3 clinical trial evaluating Fluorometholone 0.1% Oph Susp and Artificial Tears for Trachomatous Trichiasis (TT) and 4 related conditions. Completed, enrolled 2,410 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrachomatous Trichiasis (TT), Eye Diseases, Eyelid Diseases, Trachomatous, Trichiasis
CountriesEthiopia
CollaboratorsUniversity of Pennsylvania, London School of Hygiene and Tropical Medicine, Berhan Public Health and Eye Care Consultancy PLC, The Fred Hollows Foundation, Ethiopia, The Fred Hollows Foundation, Australia

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedNov 4, 2019
Enrollment StartAug 19, 2021
Primary CompletionNov 30, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.7 years ago

Interventions

Fluorometholone 0.1% Oph Suspdrug

fluorometholone 0.1% one drop twice daily for four weeks, beginning with one drop just before trachomatous trichiasis surgery on the upper lid.

Artificial Tearsdrug

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.