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Trial record 3 of 73 for:    FLAME

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

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ClinicalTrials.gov Identifier: NCT04149210
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : September 17, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
John Harold Kempen, 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

Condition or disease Intervention/treatment Phase
Trachomatous Trichiasis (TT) Eye Diseases Eyelid Diseases Trachomatous Trichiasis Drug: Fluorometholone 0.1% Oph Susp Drug: Artificial Tears Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a 1:1 randomized, double-masked, placebo controlled clinical trial
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.
Primary Purpose: Treatment
Official Title: FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial
Actual Study Start Date : August 19, 2021
Estimated Primary Completion Date : July 31, 2023
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fluorometholone
Fluorometholone 0.1% eyedrops, one drop twice daily for four weeks
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.
Other Name: FML

Placebo Comparator: Artificial Tears
one drop two times daily for four weeks
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.
Other Name: Placebo




Primary Outcome Measures :
  1. Incidence of postoperative TT by one year, as determined by trained study team members [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Efficacy Measure 1 - Entropion [ Time Frame: 1 year ]
    Entropion (presence and extent)

  2. Efficacy Measure 2 - Reoperation [ Time Frame: 1 year ]
    Reoperation for postoperative TT (recommended or done)

  3. Efficacy Measure 3 - Lashes [ Time Frame: 1 year ]
    Number and location of lashes touching the globe

  4. Safety/adverse outcomes 1 - Corneal Opacity [ Time Frame: 1 year ]
    Corneal opacity (change in proportion from baseline)

  5. Safety/adverse outcomes 2 - Overcorrection [ Time Frame: 1 year ]
    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.

  6. Safety/adverse outcomes 3 - Eyelid Abnormalities [ Time Frame: 1 year ]
    Eyelid notching/eyelid contour abnormalities

  7. Safety/adverse outcome 4 - Lid Closure Defect [ Time Frame: 1 year ]
    Lid closure defect

  8. Safety/adverse outcomes 5 - Granuloma [ Time Frame: 1 year ]
    Granuloma

  9. Safety/adverse outcomes 7 - IOP in mmHg [ Time Frame: 4 weeks ]
    IOP elevation

  10. Safety/adverse outcomes 8 - Cataract Surgery [ Time Frame: 1 year ]
    Occurrence of cataract surgery

  11. Safety/adverse outcomes - Adverse Events [ Time Frame: 1 year ]
    Adverse events attributed to study treatment

  12. Additional variables 1 - Visual Acuity [ Time Frame: 1 year ]
    Visual acuity with presenting correction



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149210


Contacts
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Contact: John H Kempen, MD MPH MHS PhD 617-573-3202 ext 7812480294 John_Kempen@MEEI.HARVARD.EDU
Contact: Tony Succar, PhD MScMed(OphthSc) 6175734436 ext 7812480294 tony_succar@meei.harvard.edu

Locations
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Ethiopia
Ministry of Science and Higher Education Ethiopia Recruiting
Addis Ababa, Ethiopia
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
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
Investigators
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Study Chair: John H Kempen, MD MPH MHS PhD Massachusetts Eye and Ear Infirmary/Harvard Medical School
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Responsible Party: John Harold Kempen, Professor, Director of Epidemiology for Ophthalmology, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT04149210    
Other Study ID Numbers: 2019P002286
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Per National Institutes of Health policy at the time.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by John Harold Kempen, Massachusetts Eye and Ear Infirmary:
fluorometholone 0.1%
trachomatous trichiasis
Eye Diseases
Eyelid Diseases
trachomatous
trichiasis
FLAME
TT Surgery
Additional relevant MeSH terms:
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Eye Diseases
Trichiasis
Eyelid Diseases
Fluorometholone
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents