Fluorometholone for Corneal Ulcer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding fluorometholone, an anti-inflammatory eye drop, to standard antibiotic treatment can improve vision in people with bacterial corneal ulcers. The study will compare this combination to antibiotics alone to determine which is more effective in enhancing vision over three months. Suitable participants should have a diagnosed bacterial corneal ulcer that hasn't fully responded to antibiotics after 48-96 hours. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early findings.
Do I need to stop my current medications for the trial?
The trial requires that you stop using topical or systemic corticosteroids during the ulcer episode. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
Is there any evidence suggesting that fluorometholone is likely to be safe for humans?
Research shows that fluorometholone, a type of steroid eye drop, is usually well-tolerated for treating eye conditions. Studies have found that it effectively reduces swelling, aiding in eye healing. Available studies report no serious side effects linked to its use.
As this trial is in an early stage, researchers continue to gather detailed safety information. However, the existing use of fluorometholone for other eye conditions offers some reassurance about its safety. Participants should always discuss potential risks and benefits with their doctor before joining a trial.12345Why do researchers think this study treatment might be promising for corneal ulcers?
Fluorometholone is unique because it is a corticosteroid that can reduce inflammation, which is a critical part of managing corneal ulcers. Unlike the standard antibiotic treatments for corneal ulcers, such as fortified Tobramycin and Cefazolin, which primarily focus on eliminating infection, Fluorometholone targets the inflammatory response, potentially speeding up healing and reducing scarring. Researchers are excited about this treatment because it could offer a more comprehensive approach to managing corneal ulcers by addressing both infection and inflammation simultaneously.
What evidence suggests that fluorometholone might be an effective treatment for corneal ulcers?
Research has shown that fluorometholone, when applied to the eye, reduces swelling, which is crucial for treating eye problems. This action manages symptoms and improves outcomes in various eye diseases. Its formulation allows easier entry into the eye, enhancing its effectiveness. Although direct proof for its use in bacterial corneal ulcers is lacking, its success in other eye conditions suggests potential benefits when combined with standard antibiotic treatments. In this trial, participants in the intervention arm will receive standard topical antibiotics, and adding fluorometholone could enhance vision recovery in patients with corneal ulcers.12456
Who Is on the Research Team?
Vishal Jhanji, MD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for patients with bacterial corneal ulcers. Participants should not have liver disease, as the medication being tested could affect liver function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either standard topical antibiotic therapy alone or in combination with fluorometholone (FML) for bacterial corneal ulcers
Follow-up
Participants are monitored for safety and effectiveness, including BCVA, re-epithelialization, and intraocular pressure
What Are the Treatments Tested in This Trial?
Interventions
- Fluorometholone
Trial Overview
The study is testing if adding a steroid eye drop called Fluorometholone (FML) to standard antibiotic treatment improves vision after 3 months in patients with bacterial corneal ulcers.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participant will be assigned Topical Antibiotics (fortified Tobramycin., fortified Cefazolin, Moxifloxacin)
Participant will be assigned Topical Antibiotics (fortified Tobramycin, fortified Cefazolin, Moxifloxacin).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vishal Jhanji
Lead Sponsor
University of Pittsburgh Medical Center
Collaborator
Citations
Therapeutic effectiveness of fluorometholone in ...
The data demonstrate that topically administered fluorometholone is an effective therapeutic agent and that it compares favorably in anti-inflammatory activity.
Study Details | NCT07308938 | Fluorometholone Study
The investigators seek to determine whether adjunctive topical fluorometholone (FML) improves best-corrected visual acuity (BCVA) at 3 months in ...
Fluorometholone for Corneal Ulcer · Info for Participants
The study is testing if adding a steroid eye drop called Fluorometholone (FML) to standard antibiotic treatment improves vision after 3 months ...
Fluorometholone acetate: More benefit than meets the eye
“The acetate in the formulation makes the drug more lipophilic, which facilitates better penetration into the ocular surface,” he explained, ...
Combination Therapy of 0.1% Fluorometholone and 0.05% ...
This study sought to evaluate the efficacy of the isolated use of fluorometholone compared with the combined use of azelastine and fluorometholone for the ...
Effect of Anti-Inflammatory Eye Drops on Bacterial Keratitis
Anti-inflammatory treatment was considered when corneal epithelial defect, corneal infiltration and anterior chamber inflammation were decreased.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.