John H. Kempen, Redda Tekle-Haimanot, Lelisa Hunduma, Menilik Alemayehu, Maxwell Pistilli, Aida Abashawl, Scott D. Lawrence, Wondu Alemayehu

To assess the hypothesis that fluorometholone 0.1% eye drops are safe and effective as adjunctive therapy for trachomatous trichiasis (TT) surgery; determining the most promising dose. Randomized, placebo-controlled, double-masked parallel dose-ranging clinical trial. Patients undergoing upper lid TT surgery at a rural Ethiopian hospital were randomized to fluorometholone 0.1% twice daily for four weeks, four times daily for four weeks, four times daily for eight weeks, or matching frequency placebo in a 3:1:3:1:3:1 ratio for one eye. Randomization was stratified by TT severity (1-4 vs. ≥5 lashes touching the globe). Safety outcomes (intraocular pressure [IOP] elevation, cataract, and other dose-limiting toxicities) and post-operative TT incidence were assessed over one year. Subjects randomized were 39:13:39:13:38:13 in the respective groups, and one subject in the eight weeks' fluorometholone group was withdrawn. 148/154 subjects (96.1%) completed one year's follow-up. Among eyes receiving fluorometholone four times daily, 1/76 developed IOP elevation≥30 mmHg (to 37 mmHg), and one had an allergic reaction attributed to the study drug; each resolved upon drug cessation without sequelae. No cataract or other dose-limiting toxicity events occurred. Post-operative TT within one year occurred in 29.3% of placebo eyes vs. 17.7%, 19.6% and 23.2% amongst the respective fluorometholone groups (p=0.29 comparing placebo vs. all active treatments combined). The results suggest fluorometholone 0.1% is likely to be safe and efficacious to reduce post-op TT following TT surgery, and one drop twice daily for four weeks is the most promising dose. Confirmation in a full-scale clinical trial is needed before programmatic implementation.