drugset / Trial / NCT07496060

Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas

NCT07496060

Phase 4 Completed 66 enrolled Fayoum University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-08-10
Primary completion
2026-01-13
Completion
2026-01-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Loteprednol Etabonate Other / unclassified 1 % Topical
Comparator Prednisolone Other / unclassified 1 % Topical

Indications