Fluorometholone 0.1% as Ancillary Therapy for Trachomatous Trichiasis Surgery: Randomized Clinical Trial

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

Research output: Contribution to journalArticle

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randomized were 39:13:39:13:38:13 in the respective groups, and 1 subject in the 8-weeks fluorometholone group was withdrawn.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'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.

LanguageEnglish (US)
Pages145-155
Number of pages11
JournalAmerican journal of ophthalmology
Volume197
DOIs
StatePublished - Jan 1 2019

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Fluorometholone
Trichiasis
Randomized Controlled Trials
Placebos
Intraocular Pressure
Cataract
Therapeutics
Clinical Trials
Rural Hospitals
Ophthalmic Solutions
Random Allocation
Pharmaceutical Preparations
Hypersensitivity
Safety

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Kempen, J. H., Tekle-Haimanot, R., Hunduma, L., Alemayehu, M., Pistilli, M., Abashawl, A., ... Alemayehu, W. (2019). Fluorometholone 0.1% as Ancillary Therapy for Trachomatous Trichiasis Surgery: Randomized Clinical Trial. American journal of ophthalmology, 197, 145-155. https://doi.org/10.1016/j.ajo.2018.09.017

Fluorometholone 0.1% as Ancillary Therapy for Trachomatous Trichiasis Surgery : Randomized Clinical Trial. / Kempen, John H.; Tekle-Haimanot, Redda; Hunduma, Lelisa; Alemayehu, Menilik; Pistilli, Maxwell; Abashawl, Aida; Lawrence, Scott David; Alemayehu, Wondu.

In: American journal of ophthalmology, Vol. 197, 01.01.2019, p. 145-155.

Research output: Contribution to journalArticle

Kempen, JH, Tekle-Haimanot, R, Hunduma, L, Alemayehu, M, Pistilli, M, Abashawl, A, Lawrence, SD & Alemayehu, W 2019, 'Fluorometholone 0.1% as Ancillary Therapy for Trachomatous Trichiasis Surgery: Randomized Clinical Trial' American journal of ophthalmology, vol. 197, pp. 145-155. https://doi.org/10.1016/j.ajo.2018.09.017
Kempen, John H. ; Tekle-Haimanot, Redda ; Hunduma, Lelisa ; Alemayehu, Menilik ; Pistilli, Maxwell ; Abashawl, Aida ; Lawrence, Scott David ; Alemayehu, Wondu. / Fluorometholone 0.1% as Ancillary Therapy for Trachomatous Trichiasis Surgery : Randomized Clinical Trial. In: American journal of ophthalmology. 2019 ; Vol. 197. pp. 145-155.
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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'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.",
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AU - Pistilli, Maxwell

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AU - Lawrence, Scott David

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