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

Mass Eye and Ear

Status and phase: Completed; Phase 3

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

Treatments: Drug: Artificial Tears; Drug: Fluorometholone 0.1% Oph Susp

Study type: Interventional

Funder types: Other

Identifiers

NCT04149210

2019P002286

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,410 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

2,410 participants in 2 patient groups, including a placebo group

fluorometholone

Experimental group

Description:

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

Treatment:

Drug: Fluorometholone 0.1% Oph Susp

Artificial Tears

Placebo Comparator group

Description:

one drop two times daily for four weeks

Treatment:

Drug: Artificial Tears