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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-19

Study Completion Date

2024-11-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Trachomatous Trichiasis (TT) Eye Diseases Eyelid Diseases Trachomatous Trichiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a 1:1 randomized, double-masked, placebo controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Patients, surgeons, and study staff at field site are masked to the assigned treatment group of the subject.

Study Groups

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fluorometholone

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

Group Type EXPERIMENTAL

Fluorometholone 0.1% Oph Susp

Intervention Type DRUG

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

Artificial Tears

one drop two times daily for four weeks

Group Type PLACEBO_COMPARATOR

Artificial Tears

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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FML Placebo

Eligibility Criteria

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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).

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No