Phase
Condition
N/ATreatment
Artificial Tears
Fluorometholone 0.1% Oph Susp
Clinical Study ID
Ages > 15 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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.
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.
Collection of all baseline data prior to randomization
Signed, informed consent (and assent, when applicable)
Exclusion
Exclusion Criteria:
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
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)
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).
Any condition known to be present at baseline for which it is anticipated ocular orsystemic corticosteroid therapy will be required.
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.
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
Study Description
Connect with a study center
Ministry of Science and Higher Education Ethiopia
Addis Ababa,
EthiopiaSite Not Available
Oromia Health Bureau
Addis Ababa,
EthiopiaSite Not Available
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