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Purpose: To report the design of FLuorometholone as Adjunctive MEdical therapy for TT surgery (FLAME) trial., Design: Parallel design, double-masked, placebo-controlled clinical trial with 1:1 randomization to fluorometholone 0.1% eye drops twice daily or placebo twice daily for 4 weeks in eyes undergoing trachomatous trichiasis (TT) surgery for assessing the efficacy, safety, and cost-effectiveness of fluorometholone 0.1% in preventing recurrent postoperative trichiasis (PTT)., Methods: Up to 2500 eligible persons with trachomatous trichiasis undergoing lid rotation surgery were enrolled in the Jimma zone, Ethiopia. Participants, surgeons, study field staff, and study supervisors leading operational aspects of the trial are masked to treatment assignment. Randomization is stratified by the surgeon and is simultaneously stratified by the district. Study visits (in addition to programmatic follow-ups) are at the baseline/enrollment, at four-week post-enrollment, and after 6 months and 1 year. The primary outcome is cumulative one-year PTT incidence, defined as: ≥1 lashes touching the globe, evidence of epilation, and/or repeat TT surgery. Secondary postoperative outcomes include the number of trichiatic lashes, location (touching the cornea or not), evidence of post-operative epilation, entropion, changes in corneal opacity, IOP elevation, need for cataract surgery, visual acuity change from the baseline, eyelid contour abnormality, granuloma, eyelid closure defect, and the occurrence of adverse events. Health economic analyses center on calculating the incremental cost per case of PTT avoided by fluorometholone treatment., Conclusion: The FLAME Trial is designed to provide evidence of the efficacy, safety, and cost-effectiveness of adjunctive topical peri-/postoperative fluorometholone 0.1% therapy with trichiasis surgery, which is hypothesized to reduce the risk of recurrent trichiasis while being acceptably safe., Clinical Trial Registration: https://www.clinicaltrials.gov/study/NCT04149210.

The purpose of this review is to delve into the clinical and research understanding of the pathophysiology and presentation of Sjögren's-related keratoconjunctivitis sicca in order address the diagnostic and management challenge that it represents, as well as to provide a basis for appreciating the pharmacotherapies designed to treat the ophthalmic symptoms of Sjögren's disease.