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CompletedNCT04149210FLAMEUpdated Mar 24, 2026Results posted

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

A Phase 3 interventional study of Fluorometholone 0.1% Oph Susp and Artificial Tears in Trachomatous Trichiasis (TT), Eye Diseases and Eyelid Diseases, sponsored by Massachusetts Eye and Ear Infirmary. Completed at 1 site in Ethiopia. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Massachusetts Eye and Ear Infirmary · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,410
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

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

Keywords

  • fluorometholone 0.1%
  • trachomatous trichiasis
  • Eye Diseases
  • Eyelid Diseases
  • trachomatous
  • trichiasis
  • FLAME
  • TT Surgery
03

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
2,410 participants (actual)

Study arms

  • Experimental
    fluorometholone

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

    Drug: Fluorometholone 0.1% Oph Susp

  • Placebo comparator
    Artificial Tears

    one drop two times daily for four weeks

    Drug: Artificial Tears

Interventions

  • DrugFluorometholone 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.

    Also known as: FML

  • DrugArtificial 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.

    Also known as: Placebo

05

What researchers measure

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.

    Time frame: 12 months

Secondary outcomes

  1. Efficacy Measure 1 - Entropion

    Presence and extent of entropion of the upper eyelid

    Time frame: 1 year

  2. Efficacy Measure 2 - Reoperation

    Number of study eyes undergoing reoperation for postoperative trichiasis

    Time frame: 1 year

  3. Efficacy Measure 3 - Lashes

    Number and location of trichiatic lashes from the upper eyelid touching the globe

    Time frame: 1 year

  4. Efficacy Measure 4 - Health Economic Analysis

    Marginal cost per case of postoperative trichiasis avoided (Cost-effectiveness in the use of Fluorometholone 0.1%)

    Time frame: 1 year

  5. Safety/Adverse Outcomes 1 - Corneal Opacity

    Presence and grade of corneal opacity in study eyes

    Time frame: 1 year

  6. Safety/Adverse Outcomes 2 - Overcorrection

    Presence of overcorrection in study eyes

    Time frame: 1 year

  7. Safety/Adverse Outcomes 3 - Eyelid Abnormalities

    Presence of eyelid notching/eyelid contour abnormalities in study eyes

    Time frame: 1 year

  8. Safety/Adverse Outcome 4 - Lid Closure Defect

    Presence of lid closure defect in study eyes

    Time frame: 1 year

  9. Safety/Adverse Outcomes 5 - Granuloma

    Presence of granuloma in study eyes at 1 year

    Time frame: 1 year

  10. Safety/Adverse Outcomes 6 - Pain Level

    Pain scale score ranges from 5 (least pain) to 20 (most pain)

    Time frame: 1 year

  11. Safety/Adverse Outcomes 7 - IOP in mmHg

    Intraocular pressure (IOP) elevation ≥ 10 mmHg from baseline in study eyes at week 4

    Time frame: 4 weeks

  12. Safety/Adverse Outcomes 8 - Cataract Surgery

    Occurrence of cataract surgery in study eyes

    Time frame: 1 year

  13. Safety/Adverse Outcomes 9 - TT in Non-study Eye

    Cumulative incidence of TT in the fellow eye by one year

    Time frame: 1 year

  14. Safety/Adverse Outcomes 10 - Adverse Events

    Adverse events attributed to study treatment by one year

    Time frame: 1 year

  15. Patient-reported Outcomes 1 - Patient Satisfaction

    Patient satisfaction level in regards to the trichiasis surgery outcome measured on a likert scale for satisfaction (from very dissatisfied to very satisfied)

    Time frame: 1 year

  16. Patient-reported Outcomes 2 - Cosmetic Outcome

    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)

    Time frame: 1 year

  17. Patient-reported Outcomes 3 - Health Utility

    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

    Time frame: 1 year

  18. Additional Variables 1 - Visual Acuity

    Visual acuity with presenting correction in study eyes

    Time frame: 1 year

06

Results

Posted Mar 24, 2026

Participant flow

Participant flow — Overall Study
MilestoneArtificial TearsFluorometholone
Started12061204
Completed11811180
Not completed2524
Withdrew: Death68
Withdrew: Lost to follow-up1414
Withdrew: Other52

Outcome measures

PrimaryIncidence 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.

Time frame:
12 months
Reported as:
Count of units · Study eyes
Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members
Study eyesArtificial TearsFluorometholone
PTT at any time during one-year follow-up — PTT at any time during one-year follow-up218213
PTT present at 4 weeks — PTT at any time during one-year follow-up3236
PTT present at 6 months — PTT at any time during one-year follow-up137136
PTT present at 12 months — PTT at any time during one-year follow-up168167
Early-onset PTT (incident by the time of the 6-month visit) — PTT at any time during one-year follow-up150146
Late-onset PTT (incident after the 6-month visit) — PTT at any time during one-year follow-up6867
Statistical analysis
  • Artificial Tears vs Fluorometholone · Regression, Logistic · p = 0.97 (P value refers to difference between groups on incidence of postoperative TT by one year, priori threshold for statistical significance is 0.05) · Risk difference (rd): 0.00 · 95% CI -0.02 to 0.02Difference between groups on incidence of postoperative TT by one year
SecondaryEfficacy Measure 1 - Entropion

Presence and extent of entropion of the upper eyelid

Time frame:
1 year
Reported as:
Count of units · Study eyes
Efficacy Measure 1 - Entropion
Study eyesArtificial TearsFluorometholone
Efficacy Measure 1 - Entropion208234
Statistical analysis
  • Artificial Tears vs Fluorometholone · Regression, Logistic · p = 0.13 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): 0.02 · 95% CI -0.01 to 0.04
SecondaryEfficacy Measure 2 - Reoperation

Number of study eyes undergoing reoperation for postoperative trichiasis

Time frame:
1 year
Reported as:
Count of units · Study eyes
Efficacy Measure 2 - Reoperation
Study eyesArtificial TearsFluorometholone
Efficacy Measure 2 - Reoperation13
Statistical analysis
  • Artificial Tears vs Fluorometholone · Fisher Exact · p = 0.37 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): 0.00 · 95% CI 0.00 to 0.00
SecondaryEfficacy Measure 3 - Lashes

Number and location of trichiatic lashes from the upper eyelid touching the globe

Time frame:
1 year
Reported as:
Mean · Lashes touching
Efficacy Measure 3 - Lashes
Lashes touchingArtificial TearsFluorometholone
Number of upper eyelid lashes touching the cornea at one year0.16 ± 0.730.13 ± 0.57
Total number of upper eyelid lashes touching the globe or the cornea at one year0.22 ± 0.860.21 ± 0.78
Statistical analysis
  • Artificial Tears vs Fluorometholone · Regression, Poisson · p = 0.75 (P value refers to difference between groups on number of upper eyelid lashes touching the globe at one year, priori threshold for statistical significance is 0.05) · Mean difference (final values): -0.01 · 95% CI -0.05 to 0.04Difference between groups on number of upper eyelid lashes touching the globe at one year
SecondaryEfficacy Measure 4 - Health Economic Analysis

Marginal cost per case of postoperative trichiasis avoided (Cost-effectiveness in the use of Fluorometholone 0.1%)

Time frame:
1 year
Reported as:
Number · cost (2026 USD)/(PTT case avoided)
Efficacy Measure 4 - Health Economic Analysis
cost (2026 USD)/(PTT case avoided)Artificial TearsFluorometholone
Efficacy Measure 4 - Health Economic Analysis055556
SecondarySafety/Adverse Outcomes 1 - Corneal Opacity

Presence and grade of corneal opacity in study eyes

Time frame:
1 year
Reported as:
Count of units · Study eyes
Safety/Adverse Outcomes 1 - Corneal Opacity
Study eyesArtificial TearsFluorometholone
No10681064
Yes532503
Statistical analysis
  • Artificial Tears vs Fluorometholone · Regression, Logistic · p = 0.53 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): -0.01 · 95% CI -0.05 to 0.03
SecondarySafety/Adverse Outcomes 2 - Overcorrection

Presence of overcorrection in study eyes

Time frame:
1 year
Reported as:
Count of units · Study eyes
Safety/Adverse Outcomes 2 - Overcorrection
Study eyesArtificial TearsFluorometholone
No15871558
Yes139
Statistical analysis
  • Artificial Tears vs Fluorometholone · Regression, Logistic · p = 0.44 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): 0.00 · 95% CI -0.01 to 0.00
SecondarySafety/Adverse Outcomes 3 - Eyelid Abnormalities

Presence of eyelid notching/eyelid contour abnormalities in study eyes

Time frame:
1 year
Reported as:
Count of units · Study eyes
Safety/Adverse Outcomes 3 - Eyelid Abnormalities
Study eyesArtificial TearsFluorometholone
No15421525
Yes5842
Statistical analysis
  • Artificial Tears vs Fluorometholone · Regression, Logistic · p = 0.17 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): -0.01 · 95% CI -0.02 to 0.00
SecondarySafety/Adverse Outcome 4 - Lid Closure Defect

Presence of lid closure defect in study eyes

Time frame:
1 year
Reported as:
Count of units · Study eyes
Safety/Adverse Outcome 4 - Lid Closure Defect
Study eyesArtificial TearsFluorometholone
No15981567
Yes20
Statistical analysis
  • Artificial Tears vs Fluorometholone · Fisher Exact · p = 0.50 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): 0.00 · 95% CI 0.00 to 0.00
SecondarySafety/Adverse Outcomes 5 - Granuloma

Presence of granuloma in study eyes at 1 year

Time frame:
1 year
Reported as:
Count of units · Study eyes
Safety/Adverse Outcomes 5 - Granuloma
Study eyesArtificial TearsFluorometholone
No15951564
Yes53
Statistical analysis
  • Artificial Tears vs Fluorometholone · Fisher Exact · p = 0.73 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): 0.00 · 95% CI 0.00 to 0.00
SecondarySafety/Adverse Outcomes 6 - Pain Level

Pain scale score ranges from 5 (least pain) to 20 (most pain)

Time frame:
1 year
Reported as:
Mean · Point
Safety/Adverse Outcomes 6 - Pain Level
PointArtificial TearsFluorometholone
Safety/Adverse Outcomes 6 - Pain Level5.35 ± 1.55.32 ± 1.4
Statistical analysis
  • Artificial Tears vs Fluorometholone · Regression, Linear · p = 0.63 (Priori threshold for statistical significance is 0.05) · Mean difference (final values): -0.03 · 95% CI -0.14 to 0.09
SecondarySafety/Adverse Outcomes 7 - IOP in mmHg

Intraocular pressure (IOP) elevation ≥ 10 mmHg from baseline in study eyes at week 4

Time frame:
4 weeks
Reported as:
Count of units · Study eyes
Safety/Adverse Outcomes 7 - IOP in mmHg
Study eyesArtificial TearsFluorometholone
No16121577
Yes57
Statistical analysis
  • Artificial Tears vs Fluorometholone · Fisher Exact · p = 0.58 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): 0.00 · 95% CI 0.00 to 0.01
SecondarySafety/Adverse Outcomes 8 - Cataract Surgery

Occurrence of cataract surgery in study eyes

Time frame:
1 year
Reported as:
Count of units · Study eyes
Safety/Adverse Outcomes 8 - Cataract Surgery
Study eyesArtificial TearsFluorometholone
No16181590
Yes73
Statistical analysis
  • Artificial Tears vs Fluorometholone · Fisher Exact · p = 0.34 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): 0.00 · 95% CI -0.01 to 0.00
SecondarySafety/Adverse Outcomes 9 - TT in Non-study Eye

Cumulative incidence of TT in the fellow eye by one year

Time frame:
1 year
Reported as:
Count of units · Fellow eye
Safety/Adverse Outcomes 9 - TT in Non-study Eye
Fellow eyeArtificial TearsFluorometholone
Number of Fellow Eye without TT406431
Number of Fellow Eye with TT107119
Statistical analysis
  • Artificial Tears vs Fluorometholone · Regression, Logistic · p = 0.76 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): 0.01 · 95% CI -0.04 to 0.06
SecondarySafety/Adverse Outcomes 10 - Adverse Events

Adverse events attributed to study treatment by one year

Time frame:
1 year
Reported as:
Count of participants · Participants
Safety/Adverse Outcomes 10 - Adverse Events
ParticipantsArtificial TearsFluorometholone
No11951197
Yes, not serious94
No surgery due to withdrawal after randomization23
Statistical analysis
  • Artificial Tears vs Fluorometholone · Fisher Exact · p = 0.27 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): 0.00 · 95% CI -0.01 to 0.00
SecondaryPatient-reported Outcomes 1 - Patient Satisfaction

Patient satisfaction level in regards to the trichiasis surgery outcome measured on a likert scale for satisfaction (from very dissatisfied to very satisfied)

Time frame:
1 year
Reported as:
Count of units · Study eyes
Patient-reported Outcomes 1 - Patient Satisfaction
Study eyesArtificial TearsFluorometholone
Very satisfied14611468
Satisfied12893
Neither satisfied nor dissatisfied54
Dissatisfied52
Very dissatisfied10
Statistical analysis
  • Artificial Tears vs Fluorometholone · Cumulative logit regression model · p = 0.04 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): 0.02 · 95% CI 0.00 to 0.04Difference between groups on incidence of reporting very satisfied with the trichiasis surgery outcome at 1 year
SecondaryPatient-reported Outcomes 2 - Cosmetic Outcome

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)

Time frame:
1 year
Reported as:
Count of units · Study eyes
Patient-reported Outcomes 2 - Cosmetic Outcome
Study eyesArtificial TearsFluorometholone
Very satisfied14581457
Satisfied136105
Neither satisfied nor dissatisfied34
Dissatisfied21
Very dissatisfied10
Statistical analysis
  • Artificial Tears vs Fluorometholone · Cumulative logit regression model · p = 0.12 (Priori threshold for statistical significance is 0.05) · Risk difference (rd): 0.01 · 95% CI 0.00 to 0.03Difference between groups on incidence of reporting very satisfied with the cosmetic outcome at 1 year
SecondaryPatient-reported Outcomes 3 - Health Utility

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

Time frame:
1 year
Reported as:
Mean · Point
Patient-reported Outcomes 3 - Health Utility
PointArtificial TearsFluorometholone
Severity index (0-25, higher is worse)6.3 ± 2.616.3 ± 2.69
Health state score (0-100, higher is better)80.2 ± 15.5179.6 ± 15.66
Statistical analysis
  • Artificial Tears vs Fluorometholone · Regression, Linear · p = 0.96 (P value refers to mean difference between groups on severity index at one year. Priori threshold for statistical significance is 0.05) · Mean difference (final values): -0.01 · 95% CI -0.22 to 0.21Mean difference between groups on severity index at one year
SecondaryAdditional Variables 1 - Visual Acuity

Visual acuity with presenting correction in study eyes

Time frame:
1 year
Reported as:
Mean · logMAR
Additional Variables 1 - Visual Acuity
logMARArtificial TearsFluorometholone
Visual acuity at 1 year0.48 ± 0.480.48 ± 0.48
Change from baseline at 1 year-0.02 ± 0.36-0.03 ± 0.33
Statistical analysis
  • Artificial Tears vs Fluorometholone · Regression, Linear · p = 0.78 (P value refers to mean difference between groups on visual acuity (logMAR) at one year. Priori threshold for statistical significance is 0.05) · Mean difference (final values): -0.01 · 95% CI -0.04 to 0.03Mean difference between groups on visual acuity (logMAR) at one year

Adverse events

Collected over From enrollment until end of follow-up, up to 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Artificial Tears6/1,206 (0.5%)83/1,206 (6.9%)382/1,206 (31.7%)
Fluorometholone8/1,204 (0.7%)88/1,204 (7.3%)287/1,204 (23.8%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventArtificial TearsFluorometholone
TRICHIASISEye disorders67/120670/1204
DEATHGeneral disorders6/12068/1204
SURGERYInvestigations0/12062/1204
GLAUCOMAEye disorders2/12060/1204
GOITREEndocrine disorders0/12061/1204
INTRAOCULAR PRESSURE INCREASEDEye disorders1/12061/1204
ABDOMINAL PAINGastrointestinal disorders0/12061/1204
DYSPEPSIAGastrointestinal disorders0/12061/1204
INTESTINAL OBSTRUCTIONGastrointestinal disorders0/12061/1204
LOWER RESPIRATORY TRACT INFECTIONInfections and infestations1/12061/1204
Most frequent other events
Most frequent other events
EventArtificial TearsFluorometholone
EYELID DISORDEREye disorders207/1206168/1204
ECTROPIONEye disorders163/1206119/1204
EYELID VASCULAR DISORDEREye disorders105/120637/1204

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Artificial TearsFluorometholoneTotal
Mean47.8 ± 15.247.3 ± 14.947.6 ± 15.1
Sex: Female, Male
Sex: Female, Male(Participants)Artificial TearsFluorometholoneTotal
Female8568361692
Male350368718
Laterality of TT Surgery
Laterality of TT Surgery(Participants)Artificial TearsFluorometholoneTotal
Unilateral7798031582
Bilateral425398823
No surgery due to withdrawal after randomization235
Reading ability: unable
Reading ability: unable(Participants)Artificial TearsFluorometholoneTotal
Count of participants108510822167
Self-reported pain or discomfort
Self-reported pain or discomfort(Participants)Artificial TearsFluorometholoneTotal
None335316651
Slight418419837
Moderate234249483
Severe182169351
Extreme375188
Ocular Surface Disease Index (OSDI) ocular symptoms score
Ocular Surface Disease Index (OSDI) ocular symptoms score(scores on a scale)Artificial TearsFluorometholoneTotal
Mean48.6 ± 29.548.5 ± 29.948.6 ± 29.7
Ocular Surface Disease Index (OSDI) total score
Ocular Surface Disease Index (OSDI) total score(scores on a scale)Artificial TearsFluorometholoneTotal
Mean37.8 ± 23.237.9 ± 23.437.9 ± 23.3
Type of TT surgery
Type of TT surgery(Study Eyes)Artificial TearsFluorometholoneTotal
BLTR5245151039
PLTR110510842189
No surgery due to withdrawal after randomization347

15 further baseline measures are reported on the registry.

07

Study locations

1 site
  • Oromia Health Bureau
    Addis Ababa, Addis Ababa, Ethiopia
08

References and documents

Publications

  • 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. PubMed 41539314 ↗
  • 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. PubMed 40737343 ↗
  • 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. PubMed 39656933 ↗
  • 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. PubMed 39006430 ↗

Study documents

  • Study protocol · Jun 29, 2023
  • Statistical analysis plan · Aug 10, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT04149210
Lead sponsor
Massachusetts Eye and Ear Infirmary
Collaborators
University of Pennsylvania, London School of Hygiene and Tropical Medicine, Berhan Public Health and Eye Care Consultancy PLC, The Fred Hollows Foundation, Ethiopia, The Fred Hollows Foundation, Australia
Responsible party
John Harold Kempen (Professor, Director of Epidemiology for Ophthalmology, Massachusetts Eye and Ear Infirmary) — Principal investigator
First posted
Nov 4, 2019
Start date
Aug 19, 2021
Primary completion
Nov 30, 2024
Completion
Nov 30, 2024
Results posted
Mar 24, 2026
Last update
Mar 24, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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