Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas

Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas: A Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Anterior Chamber Granulomatous Uveitis
• Intervention / Treatment: Drug: loteprednol etabonate 1% arm 1; Drug: prednisolone acete 1%

Detailed Description

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:

• Group 1 (Loteprednol): Received loteprednol etabonate 1% eye drops four times daily.
• Group 2 (Prednisolone): Received prednisolone acetate 1% eye drops six times daily.

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Faiyum Governorate
    • Al Fayyum, Faiyum Governorate, Egypt, 63514
      • Fayoum University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: loteprednol etabonate 1% group; 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; 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.
Active Comparator: prednisolone acetate 1% group; 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean intraocular pressure change	Comparison of the mean IOP between the two treatment groups using Goldmann applanation tonometry	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.	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.	4 weeks

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2025
• Primary Completion (Actual): January 13, 2026
• Study Completion (Actual): January 13, 2026

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: anterior chamber granuloma, anterior uveitis, loteprednol etabonate, prednisolone acetate
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Panuveitis; Uveitis; Uveitis, Anterior; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Androstadienes; Androstenes; Androstanes; Loteprednol Etabonate
• Other Study ID Numbers: R824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No