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

Last updated: February 25, 2025
Sponsor: Massachusetts Eye and Ear Infirmary
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

Artificial Tears

Fluorometholone 0.1% Oph Susp

Clinical Study ID

NCT04149210
2019P002286
  • Ages > 15
  • All Genders

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 15 years or more, corresponding to the age of patients treated in the FredHollows Foundation/Federal Ministry of Health Program at field sites without generalanesthesia.

  2. One or both eyes with upper lid trachomatous trichiasis-with one or more eyelashestouching the eye or evidence of epilation, with a plan to undergo TT surgery on atleast one upper eyelid.

  3. Collection of all baseline data prior to randomization

  4. Signed, informed consent (and assent, when applicable)

Exclusion

Exclusion Criteria:

  1. Contraindication(s) to the use of the test articles, including a known allergy orsensitivity to the study medication (fluorometholone) or its components, andcontraindication(s) to use of azithromycin

  2. IOP≥22 mmHg and/or currently taking more than two ocular anti-hypertensivemedications in the study eye (prior IOP-lowering surgery is acceptable; combinationsof two IOP-lowering agents such as Dorzamol are considered two medications)

  3. A known severe / serious ocular pathology or medical condition which may precludestudy completion or increase the risk of harm in the study (e.g., suspicion ofnon-trachomatous active ocular infection or suspicion of glaucoma of a degree towhich where an intraocular pressure spike would be vision-threatening).

  4. Any condition known to be present at baseline for which it is anticipated ocular orsystemic corticosteroid therapy will be required.

  5. Any significant illness or condition (e.g., hypertension with systolic bloodpressure≥170 mmHg and/or diastolic blood pressure≥110 mmHg) that could, in the studyteam'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 haspreviously 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 primaryanalyses).

Study Design

Total Participants: 2410
Treatment Group(s): 2
Primary Treatment: Artificial Tears
Phase: 3
Study Start date:
August 19, 2021
Estimated Completion Date:
November 30, 2024

Study 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.

Connect with a study center

  • Ministry of Science and Higher Education Ethiopia

    Addis Ababa,
    Ethiopia

    Site Not Available

  • Oromia Health Bureau

    Addis Ababa,
    Ethiopia

    Site Not Available

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