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

March 23, 2026 updated by: John Harold Kempen, Massachusetts Eye and Ear Infirmary

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators are pursuing an agenda to evaluate a new potentially cost-effective approach to improving trichiasis surgery outcomes: perioperative topical anti-inflammatory therapy. Inflammation-whether induced by the trachoma disease process or surgery itself-most likely contributes to progressive cicatrization leading to failure of lid rotation surgery in a clinically important proportion of TT cases. The investigators hypothesize that adjunctive topical fluorometholone therapy following trichiasis surgery will reduce the risk of recurrent trichiasis and will be acceptably safe. The rationale for the efficacy aspect of this hypothesis is that interruption of inflammation postoperatively would reduce postoperative scarring/contracture driven by ongoing disease-driven inflammation and/or surgically-induced inflammation thus reducing the incidence of TT recurrence (post-operative TT) and other inflammation-related outcomes.

Study Type

Interventional

Enrollment (Actual)

2410

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ethiopia
    • Addis Ababa
      • Addis Ababa, Addis Ababa, Ethiopia
        • Oromia Health Bureau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Collection of all baseline data prior to randomization
  4. Signed, informed consent (and assent, when applicable)

Exclusion Criteria:

  1. 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
  2. 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)
  3. 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).
  4. Any condition known to be present at baseline for which it is anticipated ocular or systemic corticosteroid therapy will be required.
  5. 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.
  6. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fluorometholone
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
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.
Other Names:
  • FML
Placebo Comparator: Artificial Tears
one drop two times daily for four weeks
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.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy Measure 1 - Entropion
Time Frame: 1 year
Presence and extent of entropion of the upper eyelid
1 year
Efficacy Measure 2 - Reoperation
Time Frame: 1 year
Number of study eyes undergoing reoperation for postoperative trichiasis
1 year
Efficacy Measure 3 - Lashes
Time Frame: 1 year
Number and location of trichiatic lashes from the upper eyelid touching the globe
1 year
Efficacy Measure 4 - Health Economic Analysis
Time Frame: 1 year
Marginal cost per case of postoperative trichiasis avoided (Cost-effectiveness in the use of Fluorometholone 0.1%)
1 year
Safety/Adverse Outcomes 1 - Corneal Opacity
Time Frame: 1 year
Presence and grade of corneal opacity in study eyes
1 year
Safety/Adverse Outcomes 2 - Overcorrection
Time Frame: 1 year
Presence of overcorrection in study eyes
1 year
Safety/Adverse Outcomes 3 - Eyelid Abnormalities
Time Frame: 1 year
Presence of eyelid notching/eyelid contour abnormalities in study eyes
1 year
Safety/Adverse Outcome 4 - Lid Closure Defect
Time Frame: 1 year
Presence of lid closure defect in study eyes
1 year
Safety/Adverse Outcomes 5 - Granuloma
Time Frame: 1 year
Presence of granuloma in study eyes at 1 year
1 year
Safety/Adverse Outcomes 6 - Pain Level
Time Frame: 1 year
Pain scale score ranges from 5 (least pain) to 20 (most pain)
1 year
Safety/Adverse Outcomes 7 - IOP in mmHg
Time Frame: 4 weeks
Intraocular pressure (IOP) elevation ≥ 10 mmHg from baseline in study eyes at week 4
4 weeks
Safety/Adverse Outcomes 8 - Cataract Surgery
Time Frame: 1 year
Occurrence of cataract surgery in study eyes
1 year
Safety/Adverse Outcomes 9 - TT in Non-study Eye
Time Frame: 1 year
Cumulative incidence of TT in the fellow eye by one year
1 year
Safety/Adverse Outcomes 10 - Adverse Events
Time Frame: 1 year
Adverse events attributed to study treatment by one year
1 year
Patient-reported Outcomes 1 - Patient Satisfaction
Time Frame: 1 year
Patient satisfaction level in regards to the trichiasis surgery outcome measured on a likert scale for satisfaction (from very dissatisfied to very satisfied)
1 year
Patient-reported Outcomes 2 - Cosmetic Outcome
Time Frame: 1 year
Patient satisfaction level in regards to the cosmetic outcome of the trichiasis surgery measured on a likert scale for satisfaction (from very dissatisfied to very satisfied)
1 year
Patient-reported Outcomes 3 - Health Utility
Time Frame: 1 year
Quality of life assessed using the tool EuroQol 5 Dimensions (EQ-5D) comprising mobility, self-care, usual activities, pain/discomfort and anxiety/depression dimensions and assessed on five levels from no problems to extreme problems
1 year
Additional Variables 1 - Visual Acuity
Time Frame: 1 year
Visual acuity with presenting correction in study eyes
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts Eye and Ear Infirmary

Collaborators

London School of Hygiene and Tropical Medicine
University of Pennsylvania
The Fred Hollows Foundation, Ethiopia
The Fred Hollows Foundation, Australia
Berhan Public Health and Eye Care Consultancy PLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2021

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

October 12, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019P002286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eye Diseases

Clinical Trials on Fluorometholone 0.1% Oph Susp

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe