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

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

Interventions

DRUG

Fluorometholone 0.1% Oph Susp

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

DRUG

Artificial Tears

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.

Sponsors & Collaborators

• University of Pennsylvania

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Berhan Public Health and Eye Care Consultancy PLC

  collaborator OTHER

• The Fred Hollows Foundation, Ethiopia

  collaborator UNKNOWN

• The Fred Hollows Foundation, Australia

  collaborator UNKNOWN

• Massachusetts Eye and Ear Infirmary

  lead OTHER

Principal Investigators

• John H Kempen, MD MPH MHS PhD · Massachusetts Eye and Ear Infirmary/Harvard Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-19

Primary Completion

2024-11-30

Completion

2024-11-30

Countries

• Ethiopia

Study Locations