@article {1333852, title = {Fluorometholone 0.1\% as Ancillary Therapy for Trachomatous Trichiasis Surgery: Randomized Clinical Trial}, journal = {Am J Ophthalmol}, volume = {197}, year = {2019}, month = {2019 Jan}, pages = {145-155}, abstract = {PURPOSE: 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. DESIGN: Randomized, placebo-controlled, double-masked parallel dose-ranging clinical trial. METHODS: Patients undergoing upper lid TT surgery at a rural Ethiopian hospital were randomized to fluorometholone 0.1\% twice daily for 4\ weeks, 4 times daily for 4\ weeks, 4 times daily for 8\ weeks, or matching frequency placebo in a 3:1:3:1:3:1 ratio for 1 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 postoperative TT incidence were assessed over 1 year. RESULTS: Subjects randomized were 39:13:39:13:38:13 in the respective groups, and 1 subject in the 8-weeks fluorometholone group was withdrawn. Of 154 subjects, 148 (96.1\%) completed 1 year{\textquoteright}s follow-up. Among 76 eyes receiving fluorometholone 4 times daily, 1 developed IOP elevation >= 30\ mm Hg (to 37\ mm Hg) and 1 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. Postoperative TT within 1 year occurred in 29.3\% of placebo eyes vs 17.7\%, 19.6\%, and 23.2\% among the respective fluorometholone groups (P\ = .29 comparing placebo vs all active treatments combined). CONCLUSIONS: The results suggest fluorometholone 0.1\% is likely to be safe and efficacious to reduce postoperative TT following TT surgery, and 1 drop twice daily for 4\ weeks is the most promising dose. Confirmation in a full-scale clinical trial is needed before programmatic implementation.}, issn = {1879-1891}, doi = {10.1016/j.ajo.2018.09.017}, author = {Kempen, John H and Tekle-Haimanot, Redda and Hunduma, Lelisa and Alemayehu, Menilik and Pistilli, Maxwell and Abashawl, Aida and Lawrence, Scott D and Alemayehu, Wondu} }