UPMC Vision Institute
Pittsburgh, Pennsylvania, 15219, United States
NCT Number: NCT07308938
The investigators seek to determine whether adjunctive topical fluorometholone (FML) improves best-corrected visual acuity (BCVA) at 3 months in patients with bacterial corneal ulcers compared with standard topical antibiotic therapy alone.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Pittsburgh, Pennsylvania, 15219, United States
In this prospective, randomized, parallel-group clinical cohort study, the investigators seek to determine whether adjunctive topical fluorometholone (FML) improves best-corrected visual acuity (BCVA) at 3 months in patients with bacterial corneal ulcers compared with standard topical antibiotic therapy alone. The primary objective is to compare the mean 3-month BCVA (logMAR) between the intervention arm (standard topical antibiotic therapy + FML 0.1%) and a control arm (standard topical antibiotic therapy alone).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Adjunctive Topical Fluorometholone (FML) 0.1% will be used
Patients will be treated with antibiotics (Cefazolin, Tobramycin or Moxifloxacin) we per treating physician
Time frame: From enrollment to 3 months
BCVA (logMAR) at 3 months post-randomization in the study eye.
Time frame: From enrollment (Day 1) to Week 1, Month 1, Month 3.
Change in BCVA from baseline to weeks 1 and 4, and 3 months.
Time frame: From enrollment to 3 months
Time to re-epithelialization
Time frame: From enrollment (Day 1) to Day 3, 1 Week, 1 Month, 3 Months.
IOP measurements at all follow-up visits.
Time frame: From enrollment to Month 3.
Progressive thinning or perforation; hypopyon development or increase; endophthalmitis; fibrin formation; or worsening infiltrate size or depth ≥50%.
Trial opening soon.
Get NotifiedVishal Jhanji
Other
Trial of Topical Fluorometholone as Adjunctive Therapy for Bacterial Corneal Ulcers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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