FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial

NCT04149210 | Completed Phase 3 Results DMC

• 1 other identifier: 2019P002286
• Study Type: interventional
• Target: 2,410
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims :

• To assess the efficacy of fluorometholone 0.1% one drop twice daily for four weeks in reducing the incidence of post-operative trachomatous trichiasis (TT) when given as adjunctive therapy with TT surgery in the programmatic setting
• To assess whether such treatment is sufficiently safe for wide-scale implementation in TT programs.
• To estimate the costs of adding fluorometholone 0.1% treatment to TT surgery per case of postoperative TT averted, and to characterize the value of such treatment under a range of plausible health economic circumstances

Conditions

Trachomatous Trichiasis (TT); Eye Diseases; Eyelid Diseases; Trachomatous; Trichiasis

Keywords

fluorometholone 0.1%; trachomatous trichiasis; Eye Diseases; Eyelid Diseases; trachomatous; trichiasis; FLAME; TT Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members

  The primary outcome measure is the postoperative recurrence of trachomatous trichiasis (TT), defined as one or more eyelashes in the upper eyelid touching the globe or evidence of epilation (lash stubs) in the upper eyelid on examination, or a history of repeat trichiasis surgery at any time in the upper eyelid during the one year follow-up period after the baseline surgery.

  12 months

Secondary Outcomes (18)

• Efficacy Measure 1 - Entropion

  1 year

• Efficacy Measure 2 - Reoperation

  1 year

• Efficacy Measure 3 - Lashes

  1 year

• Efficacy Measure 4 - Health Economic Analysis

  1 year

• Safety/Adverse Outcomes 1 - Corneal Opacity

  1 year

Study Arms (2)

fluorometholone

EXPERIMENTAL

Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks

Drug: Fluorometholone 0.1% Oph Susp

Artificial Tears

PLACEBO COMPARATOR

one drop two times daily for four weeks

Drug: Artificial Tears

Interventions

Fluorometholone 0.1% Oph Susp DRUG

fluorometholone 0.1% one drop twice daily for four weeks, beginning with one drop just before trachomatous trichiasis surgery on the upper lid.

Also known as: FML

fluorometholone

Artificial Tears DRUG

Artificial tears (placebo) given one drop twice daily for four weeks, beginning with one drop just prior to trachomatous trichiasis surgery on the upper lid.

Also known as: Placebo

Artificial Tears

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 15 years or more, corresponding to the age of patients treated in the Fred Hollows Foundation/Federal Ministry of Health Program at field sites without general anesthesia.
• One or both eyes with upper lid trachomatous trichiasis-with one or more eyelashes touching the eye or evidence of epilation, with a plan to undergo TT surgery on at least one upper eyelid.
• Collection of all baseline data prior to randomization
• Signed, informed consent (and assent, when applicable)

You may not qualify if:

• Contraindication(s) to the use of the test articles, including a known allergy or sensitivity to the study medication (fluorometholone) or its components, and contraindication(s) to use of azithromycin
• IOP≥22 mmHg and/or currently taking more than two ocular anti-hypertensive medications in the study eye (prior IOP-lowering surgery is acceptable; combinations of two IOP-lowering agents such as Dorzamol are considered two medications)
• A known severe / serious ocular pathology or medical condition which may preclude study completion or increase the risk of harm in the study (e.g., suspicion of non-trachomatous active ocular infection or suspicion of glaucoma of a degree to which where an intraocular pressure spike would be vision-threatening).
• Any condition known to be present at baseline for which it is anticipated ocular or systemic corticosteroid therapy will be required.
• Any significant illness or condition (e.g., hypertension with systolic blood pressure≥170 mmHg and/or diastolic blood pressure≥110 mmHg) that could, in the study team's opinion, be expected to interfere with the study parameters or study conduct; or put the subject at significant risk.
• Previous upper lid TT surgery on all eyes with upper lid TT. (If one eye has previously undergone upper lid TT surgery but another eye with upper lid TT has not, the patient may be enrolled, and only the latter eye will be counted for the primary analyses).

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead
• University of Pennsylvania: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• Berhan Public Health and Eye Care Consultancy PLC: collaborator
• The Fred Hollows Foundation, Ethiopia: collaborator
• The Fred Hollows Foundation, Australia: collaborator

Study Sites (1)

Oromia Health Bureau

Addis Ababa, Addis Ababa, Ethiopia

Location

Related Publications (4)

• Kempen JH, Abashawl A, Mohammed AA, Dodson S, Alemayehu W, Jin F, Gemechu A, Mengesha AA, Kumsa DA, Chen Y, McWilliams K, Tulu B, Abdela G, Megersa A, Cheru T, Mohammad G, Succar T, Bunya VY, Frick KD, Maguire MG, Burton MJ, Ying GS; FLAME Trial Research Group. 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. Lancet Glob Health. 2026 Mar;14(3):e395-e406. doi: 10.1016/S2214-109X(25)00493-0. Epub 2026 Jan 12.

  PMID: 41539314 DERIVED

• Kempen JH, Chen Y, Abashawl A, Mohammed AA, Dodson S, Alemayehu W, Gemechu A, Mengesha AA, Kumsa DA, Succar T, McWilliams K, Jin F, Bunya VY, Maguire MG, Burton MJ, Ying GS; FLuorometholone as Adjunctive MEdical Therapy for Trachomatous Trichiasis Surgery (FLAME) Trial Research Group. Outcomes of posterior lamellar tarsal rotation vs bilamellar tarsal rotation for trachomatous trichiasis. PLoS Negl Trop Dis. 2025 Jul 30;19(7):e0013152. doi: 10.1371/journal.pntd.0013152. eCollection 2025 Jul.

  PMID: 40737343 DERIVED

• Mohammed AA, Abashawl A, Dodson S, Alemayehu W, Gemechu A, Abateneh A, Kumsa D, Succar T, Chen Y, McWilliams K, Bunya VY, Maguire MG, Burton MJ, Ying GS, Kempen JH; FLuorometholone as Adjunctive MEdical Therapy for Trachomatous Trichiasis Surgery (FLAME) Trial Research Group. The FLuorometholone as Adjunctive MEdical Therapy for Trachomatous Trichiasis Surgery (FLAME) Trial: Study Design. Ophthalmic Epidemiol. 2024 Dec;31(6):611-619. doi: 10.1080/09286586.2024.2415052. Epub 2024 Dec 10.

  PMID: 39656933 DERIVED

• Mohammed AA, Abashawl A, Dodson S, Alemayehu W, Gemechu A, Mengesha AA, Kumsa D, Succar T, Chen Y, McWilliams K, Bunya VY, Maguire MG, Burton MJ, Ying GS, Kempen JH; FLuorometholone as Adjunctive MEdical Therapy for Trachomatous Trichiasis Surgery (FLAME) Trial Research Group. The FLuorometholone as Adjunctive MEdical Therapy for Trachomatous Trichiasis Surgery (FLAME) Trial: Study Design. medRxiv [Preprint]. 2024 Jul 7:2024.06.26.24308549. doi: 10.1101/2024.06.26.24308549.

  PMID: 39006430 DERIVED

MeSH Terms

Conditions

Eye Diseases; Eyelid Diseases; Trichiasis

Interventions

Fluorometholone; Lubricant Eye Drops

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: John Kempen, MD, MPH, PhD, MHS
• Organization: Massachusetts Eye and Ear

john_kempen@meei.harvard.edu

+1-617-573-4494

Study Officials

• John H Kempen, MD MPH MHS PhD

  Massachusetts Eye and Ear Infirmary/Harvard Medical School

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients, surgeons, and study staff at field site are masked to the assigned treatment group of the subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Epidemiology for Ophthalmology

Model Details: This is a 1:1 randomized, double-masked, placebo controlled clinical trial

Study Record Dates

• First Submitted: October 12, 2019
• First Posted: November 4, 2019
• Study Start: August 19, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 24, 2026
• Results First Posted: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)