Evaluation of fluorometholone as adjunctive medical therapy for trachomatous trichiasis surgery (FLAME): a parallel, double-blind, randomised controlled field trial in the Jimma Zone, Ethiopia

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BACKGROUND: In trachoma, trachomatous trichiasis mediates visual impairment. Trachomatous trichiasis surgery has an unacceptably high relapse incidence. We hypothesised that anti-inflammatory therapy with fluorometholone 0·1% suspension (hereafter fluorometholone) eyedrops perioperatively twice daily for 28 days would safely, efficaciously, and cost-effectively reduce postoperative trachomatous trichiasis relapse (PTT). METHODS: In this randomised, parallel, placebo-controlled trial, we compared placebo (artificial tears) with fluorometholone for eyes undergoing trachomatous trichiasis surgery in participants aged 15 years and older at rural health centres and post sites in the Jimma zone, Ethiopia. Participants were randomly allocated (1:1) to either placebo or fluorometholone. Treatment randomisation was stratified and blocked by surgeon. Participants, surgeons, and outcome assessors were masked to treatment assignment. Outcomes were evaluated at 4 weeks, 6 months, and 12 months postoperatively. The primary outcome was cumulative 12-month incidence of PTT, defined as any of: one or more lashes touching the globe; evidence of epilation; or occurrence of repeat trachomatous trichiasis surgery. This study is registered with ClinicalTrials.gov, NCT04149210. FINDINGS: Between Aug 19, 2021, and Nov 30, 2024, 2410 participants (1692 [70·2%] self-reported as female and 718 [29·8%] as male; 3235 eyes) were recruited. 1204 participants were randomly allocated to fluorometholone and 1206 to placebo. 823 (34·1%) participants had bilateral trachomatous trichiasis surgery. Baseline treatment group characteristics were similar; 1180 (98·0%) participants in the fluorometholone group and 1181 (97·9%) in the placebo group were evaluated at the 12-month timepoint. In the intention-to-treat analysis, the cumulative incidences of PTT during 12 months of follow-up were 218 (13·4%) of 1625 eyes in the placebo group and 213 (13·4%) of 1593 eyes in the fluorometholone group (95% CI for difference -2% to 2%). Prespecified secondary efficacy and safety outcomes were not statistically different between groups (all p≥0·10). The incidence of adverse events attributed to study treatment was nine (0·7%) in the placebo group and four (0·3%) in the fluorometholone group (p=0·17); satisfaction with surgery (satisfied or very satisfied) was recorded for 3156 (99·7%) of 3167 eyes. Health economic considerations did not favour programmatic use of fluorometholone given its inefficacy. INTERPRETATION: Fluorometholone twice daily for 4 weeks was safe but not efficacious or cost-effective for reducing PTT, and hence is not recommended for programmatic use. FUNDING: National Eye Institute (National Institutes of Health) and AbbVie. TRANSLATIONS: For the Amharic and Oromifa translations of the abstract see Supplementary Materials section.

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