A Phase 4 interventional study of loteprednol etabonate 1% arm 1 and prednisolone acete 1% in Anterior Chamber Granulomatous Uveitis, sponsored by Fayoum University. Completed at 1 site in Egypt. Open to participants aged 4 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Fayoum University · Phase 4, Interventional, and Treatment
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:
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.
The objective of this prospective, randomized, comparative clinical trial was to evaluate the therapeutic equivalence and safety profile of two commonly used topical corticosteroids in the management of pediatric anterior chamber (AC) granulomas.
While topical steroids are the established first-line therapy for this condition, steroid-induced intraocular pressure (IOP) elevation remains a significant clinical concern, particularly in pediatric populations.
Study Methodology and Intervention:
Participants were randomized into two treatment arms to receive different topical regimens:
The treatment followed a standardized protocol where dosing was spaced throughout waking hours, and bottles of prednisolone acetate (a suspension) were shaken before use to ensure dose uniformity.
Following the initial fixed-dosing phase, a clinician-guided tapering schedule was implemented based on the improvement of SUN anterior chamber activity and the reduction or clearance of the AC lesion observed during slit-lamp examinations.
Clinical Monitoring and Safety Safeguards; Patient assessments were conducted at baseline, day 1, 2 weeks, 1 month, and 3 months.
These evaluations included: Inflammatory Grading: Standardized SUN criteria for AC cells and flare.
Lesion Assessment: Slit-lamp examination to categorize granuloma status as persistent, improved, or resolved.Safety Monitoring: Goldmann applanation tonometry was used to measure IOP at every visit, with specific safety endpoints defined as IOP > 21 mmHg, or an increase from baseline > 5 mmHg.
To prioritize patient safety, a strict "non-responder" protocol was enforced. Any patient who failed to demonstrate adequate clinical improvement (defined as persistent granuloma or clinically significant inflammation despite protocol-driven treatment) after 4 weeks was classified as a non-responder and immediately referred for surgical intervention.
Scientific Rationale:
The study aimed to determine if the "soft drug" design of loteprednol etabonate-which undergoes rapid transformation to inactive metabolites-could achieve similar anti-inflammatory results as the ketone-based prednisolone acetate while reducing the risk of extracellular matrix remodeling in the trabecular meshwork that typically drives steroid-induced ocular hypertension.
54 studies on the registry are indexed under Uveitis, Anterior; 9 are open to participants now.
This study's enrollment of 66 is above the median of 45 across 42 interventional studies indexed under Uveitis, Anterior.
Browse Uveitis, Anterior studies →Fayoum University is the lead sponsor of 144 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this group received loteprednol etabonate 1% eye drops administered four times daily. The treatment was followed by a clinician-guided tapering schedule based on the clinical improvement of anterior chamber activity and the reduction or clearance of the lesion as observed on slit-lamp examination.
Drug: loteprednol etabonate 1% arm 1
Participants in this group received prednisolone acetate 1% eye drops administered six times daily. As this medication is a suspension, patients were instructed to shake the bottle before each instillation. Similar to the first group, doses were tapered by the treating clinician according to the patient's clinical response and reduction in SUN anterior chamber grading.
Drug: prednisolone acete 1%
Topical corticosteroid eye drops administered four times daily. The treatment includes a clinician-guided tapering schedule based on the improvement of SUN anterior chamber activity and the reduction or clearance of the anterior chamber lesion.
Topical corticosteroid eye drops administered six times daily. Patients are instructed to shake the bottle before each instillation to ensure dose uniformity. The treatment includes a clinician-guided tapering schedule based on clinical response.
resolution of the anterior chamber inflammation and granulomas.
The percentage of patients achieving a "clear anterior chamber," defined as the complete resolution of the inflammatory nodule (granuloma) and the absence of anterior chamber cells (SUN grade 0).
Time frame: 4 weeks
mean intraocular pressure change
Comparison of the mean IOP between the two treatment groups using Goldmann applanation tonometry
Time frame: 1 month and 3 month
Incidence of Steroid-Related IOP Elevation
The percentage of participants meeting prespecified safety thresholds: IOP \> 21 mmHg, IOP or an increase from baseline (Delta IOP) \> 5 mmHg.
Time frame: throughout 3 months
Rate of Pharmacological Non-Response
The proportion of patients who fail to show clinical improvement (persistent granuloma or significant inflammation) and require referral for surgical management.
Time frame: 4 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Fayoum University