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

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

Sponsors

Lead Sponsor: Massachusetts Eye and Ear Infirmary

Collaborator: 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

Source Massachusetts Eye and Ear Infirmary
Brief 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

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.

Overall Status Not yet recruiting
Start Date 2021-04-01
Completion Date 2024-08-31
Primary Completion Date 2023-07-31
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of postoperative TT by one year, as determined by trained study team members 12 months
Secondary Outcome
Measure Time Frame
Efficacy Measure 1 - Entropion 1 year
Efficacy Measure 2 - Reoperation 1 year
Efficacy Measure 3 - Lashes 1 year
Safety/adverse outcomes 1 - Corneal Opacity 1 year
Safety/adverse outcomes 2 - Overcorrection 1 year
Safety/adverse outcomes 3 - Eyelid Abnormalities 1 year
Safety/adverse outcome 4 - Lid Closure Defect 1 year
Safety/adverse outcomes 5 - Granuloma 1 year
Safety/adverse outcomes 7 - IOP in mmHg 4 weeks
Safety/adverse outcomes 8 - Cataract Surgery 1 year
Safety/adverse outcomes - Adverse Events 1 year
Additional variables 1 - Visual Acuity 1 year
Enrollment 2254
Condition
Intervention

Intervention Type: Drug

Intervention Name: Fluorometholone 0.1% Oph Susp

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

Arm Group Label: fluorometholone

Other Name: FML

Intervention Type: Drug

Intervention Name: Artificial Tears

Description: 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.

Arm Group Label: Artificial Tears

Other Name: Placebo

Eligibility

Criteria:

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, in association with tarsal conjunctival scarring-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).

Gender: All

Minimum Age: 15 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
John H Kempen, MD MPH MHS PhD Study Chair Massachusetts Eye and Ear Infirmary/Harvard Medical School
Overall Contact

Last Name: John H Kempen, MD MPH MHS PhD

Phone: 617-573-3202

Phone Ext.: 7812480294

Email: [email protected]

Verification Date

2021-02-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Massachusetts Eye and Ear Infirmary

Investigator Full Name: John Harold Kempen

Investigator Title: Professor, Director of Epidemiology for Ophthalmology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: fluorometholone

Type: Experimental

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

Label: Artificial Tears

Type: Placebo Comparator

Description: one drop two times daily for four weeks

Acronym FLAME
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Masking Description: There will be masking of patients, surgeons and study staff at field site to the assigned treatment group of the subject.

Source: ClinicalTrials.gov

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