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.

The most likely explanation for the apparent discrepancy between our preliminary trial results—which suggested a benefit of fluorometholone—and the negative results of the definitive FLAME trial is that the former results were observed by chance; the apparent benefit did not reach statistical significance, being a phase 2-like trial designed to show potential effectiveness in relation to doses rather than to prove efficacy.

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