# Fluoromethelone as Adjunctive Medical Therapy for TT Surgery (FLAME) Trial

> **NIH NIH UG1** · UNIVERSITY OF PENNSYLVANIA · 2022 · $329,425

## Abstract

Trachoma, the leading infectious cause of blindness worldwide. Trachomatous trichiasis (TT), a
complication of the chronic trachoma-induced cicatrization, is a key mechanism leading to
blindness from trachoma. Currently, surgery to relieve trichiasis is a key global programmatic
strategy to prevent trachoma blindness. Unfortunately, an undesirably high recurrence rate
(about 20-30%) following TT surgery. Inflammation due to surgery itself and/or the trachomatous
pathogenic process likely contributes to TT recurrence. Our preliminary trial found that anti-
inflammatory fluorometholone 0.1% eyedrops was associated with ~1/3 lower risk of one-year TT
recurrence than the placebo group, and fluorometholone 0.1% had minimal side effects.
The FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial is a double-
masked placebo-controlled randomized clinical trial to evaluate the efficacy, safety and cost-
effectiveness of fluorometholone 0.1% eyedrops as an adjunctive therapy for TT surgery in
Ethiopia.
The Data Center (DC) will collaborate closely with the Study Chairman's Office, the Field
Coordinating Center (FCC) in Ethiopia, the Executive Committee (EC), and the Data Safety
Monitoring Committee (DSMC) to ensure the success of the trial. The DC's role for this trial is to
provide leadership and expertise on design of trials, implementation and maintenance of high
quality data management system, statistical analysis and publication of trial findings.
Results of this trial will provide Level 1 evidence as to whether fluorometholone 0.1% eyedrops
should be recommended as a programmatically useful strategy for widespread adoption into
trachoma blindness alleviation programs. Proof of the efficacy, safety and its cost-effectiveness of
fluorometholone 0.1% eyedrops would provide an opportunity to improve the treatment of TT and
reduce the visual impairment and the blindness from TT globally.

## Key facts

- **NIH application ID:** 10443741
- **Project number:** 5UG1EY030419-04
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Gui-shuang Ying
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $329,425
- **Award type:** 5
- **Project period:** 2019-09-30 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10443741

## Citation

> US National Institutes of Health, RePORTER application 10443741, Fluoromethelone as Adjunctive Medical Therapy for TT Surgery (FLAME) Trial (5UG1EY030419-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10443741. Licensed CC0.

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