Phase 3
N=2,410
FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial
Trachomatous Trichiasis (TT) · Eye Diseases · Eyelid Diseases · Trachomatous · Trichiasis
Bottom Line
View on ClinicalTrials.gov: NCT04149210 ↗Enrolled (actual)
2,410
Serious AEs
7.1%
Results posted
Mar 2026
Primary outcome: Primary: Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members — 218; 213; 32; 36 Study eyes — p=0.97
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluorometholone 0.1% Oph Susp (Drug); Artificial Tears (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Postoperative TT by One Year, as Determined by Trained Study Team Members |
218; 213; 32; 36; 137; 136 | 0.97 |
| SECONDARY Efficacy Measure 1 - Entropion |
208; 234 | 0.13 |
| SECONDARY Efficacy Measure 2 - Reoperation |
1; 3 | 0.37 |
| SECONDARY Efficacy Measure 3 - Lashes |
0.16; 0.13; 0.22; 0.21 | 0.75 |
| SECONDARY Efficacy Measure 4 - Health Economic Analysis |
0; 55556 | — |
| SECONDARY Safety/Adverse Outcomes 1 - Corneal Opacity |
1068; 1064; 532; 503 | 0.53 |
| SECONDARY Safety/Adverse Outcomes 2 - Overcorrection |
1587; 1558; 13; 9 | 0.44 |
| SECONDARY Safety/Adverse Outcomes 3 - Eyelid Abnormalities |
1542; 1525; 58; 42 | 0.17 |
| SECONDARY Safety/Adverse Outcome 4 - Lid Closure Defect |
1598; 1567; 2; 0 | 0.50 |
| SECONDARY Safety/Adverse Outcomes 5 - Granuloma |
1595; 1564; 5; 3 | 0.73 |
| SECONDARY Safety/Adverse Outcomes 6 - Pain Level |
5.35; 5.32 | 0.63 |
| SECONDARY Safety/Adverse Outcomes 7 - IOP in mmHg |
1612; 1577; 5; 7 | 0.58 |
| SECONDARY Safety/Adverse Outcomes 8 - Cataract Surgery |
1618; 1590; 7; 3 | 0.34 |
| SECONDARY Safety/Adverse Outcomes 9 - TT in Non-study Eye |
406; 431; 107; 119 | 0.76 |
| SECONDARY Safety/Adverse Outcomes 10 - Adverse Events |
1195; 1197; 9; 4; 2; 3 | 0.27 |
| SECONDARY Patient-reported Outcomes 1 - Patient Satisfaction |
1461; 1468; 128; 93; 5; 4 | 0.04 sig |
| SECONDARY Patient-reported Outcomes 2 - Cosmetic Outcome |
1458; 1457; 136; 105; 3; 4 | 0.12 |
| SECONDARY Patient-reported Outcomes 3 - Health Utility |
6.3; 6.3; 80.2; 79.6 | 0.96 |
| SECONDARY Additional Variables 1 - Visual Acuity |
0.48; 0.48; -0.02; -0.03 | 0.78 |
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
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT04149210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.