Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas (NCT07496060) | Clinical Trial Compass
CompletedPhase 4
Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas
Egypt66 participantsStarted 2025-08-10
Plain-language summary
The goal of this clinical trial is to compare the efficacy and safety of two different topical corticosteroids in 66 pediatric patients with active anterior chamber granuloma.
The main questions it aims to answer are:
* Does Loteprednol Etabonate 1% provide equivalent inflammation control and granuloma resolution compared to Prednisolone Acetate 1% over a 3-month period?
* Does Loteprednol Etabonate 1% result in a lower frequency of steroid-related intraocular pressure (IOP) elevations than Prednisolone Acetate 1%? Researchers compared a group receiving Loteprednol Etabonate 1% four times daily to a group receiving Prednisolone Acetate 1% six times daily to see if Loteprednol could maintain comparable therapeutic effectiveness while offering a safer intraocular pressure profile.
Participants will Be randomized to receive either Loteprednol Etabonate 1% or Prednisolone Acetate 1% eye drops.
Follow a specific dosing schedule (4 times/day for Loteprednol or 6 times/day for Prednisolone).
Undergo a clinician-guided medication tapering schedule based on clinical response.
Attend follow-up assessments at day 1, 2 weeks, 1 month, and 3 months for eye examinations and pressure monitoring.
Be referred for surgical management if they do not demonstrate adequate clinical improvement after 4 weeks of therapy.
Who can participate
Age range
4 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Any patient presenting with an active anterior chamber granuloma.
* Patients must be treatment-naïve, having received no previous medical treatment for the current condition.
* Willingness of the parent or legal guardian to provide written informed consent.
Exclusion Criteria:
* History of recurrent uveitis.
* Pre-existing glaucoma or a baseline intraocular pressure greater than 21 mmHg.
* Presence of a cataract.
* Active corneal infection or corneal ulcer.
* Active inflammation clearly attributed to trauma, lens-induced causes, or underlying rheumatologic disease.
* Evidence of active posterior uveitis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial directly compared loteprednol etabonate to prednisolone acetate for anterior chamber granulomatous uveitis — the same condition I have — can you tell me what the results showed about which steroid worked better at clearing the inflammation and granulomas?
2Both of these eye drops are already FDA-approved steroids, and this was a Phase 4 trial, so there's real-world safety experience with both — can you walk me through the known side effect differences between loteprednol etabonate and prednisolone acetate, particularly around eye pressure and cataract risk?
3Now that this trial is completed, does the data change which of these two steroid eye drops you would recommend for my specific case of granulomatous uveitis?
4Are there situations where the results from this trial might not apply to me — for example, if my uveitis is caused by a specific underlying condition like sarcoidosis or another systemic disease?
5Before considering either of these treatment options, is there a standard-of-care approach you'd recommend first, or would one of these steroid drops already be your starting point for treating my anterior chamber granulomas?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
resolution of the anterior chamber inflammation and granulomas.