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

Eye Diseases Clinical Trial

— FLAME  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04149210
• Other study ID #: 2019P002286
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 14, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: January 2024
• Source: Massachusetts Eye and Ear Infirmary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2410
• Est. completion date: December 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Eye Diseases
• Eyelid Diseases
• Trachomatous
• Trachomatous Trichiasis (TT)
• Trichiasis

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Ethiopia	Ministry of Science and Higher Education Ethiopia	Addis Ababa

Sponsors (6)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary	Berhan Public Health and Eye Care Consultancy PLC, London School of Hygiene and Tropical Medicine, The Fred Hollows Foundation, Australia, The Fred Hollows Foundation, Ethiopia, University of Pennsylvania

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative TT by one year, as determined by trained study team members	The primary outcome measure is the postoperative recurrence of trachomatous trichiasis (TT), defined as one or more eyelashes touching the globe or evidence of epilation (lash stubs) on examination, or a history of repeat trichiasis surgery at any time during the one year follow-up period after the baseline surgery.	12 months
Secondary	Efficacy Measure 1 - Entropion	Entropion (presence and extent)	1 year
Secondary	Efficacy Measure 2 - Reoperation	Reoperation for postoperative TT (recommended or done)	1 year
Secondary	Efficacy Measure 3 - Lashes	Number and location of lashes touching the globe	1 year
Secondary	Safety/adverse outcomes 1 - Corneal Opacity	Corneal opacity (change in proportion from baseline)	1 year
Secondary	Safety/adverse outcomes 2 - Overcorrection	Overcorrection - The surgery rotates the eyelid away from the eyeball (the disease consists of inturning of the eyelid such that the lashes touch the eyeball). Overcorrection would be rotating it away from the globe.	1 year
Secondary	Safety/adverse outcomes 3 - Eyelid Abnormalities	Eyelid notching/eyelid contour abnormalities	1 year
Secondary	Safety/adverse outcome 4 - Lid Closure Defect	Lid closure defect	1 year
Secondary	Safety/adverse outcomes 5 - Granuloma	Granuloma	1 year
Secondary	Safety/adverse outcomes 7 - IOP in mmHg	IOP elevation	4 weeks
Secondary	Safety/adverse outcomes 8 - Cataract Surgery	Occurrence of cataract surgery	1 year
Secondary	Safety/adverse outcomes - Adverse Events	Adverse events attributed to study treatment	1 year
Secondary	Additional variables 1 - Visual Acuity	Visual acuity with presenting correction	1 year