Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas

NCT07496060 | Completed Phase 4 DMC

• 1 other identifier: R824
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anterior Chamber Granulomatous Uveitis

Keywords

anterior chamber granuloma, anterior uveitis, loteprednol etabonate, prednisolone acetate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• mean intraocular pressure change

  1 month and 3 month

• Incidence of Steroid-Related IOP Elevation

  throughout 3 months

• Rate of Pharmacological Non-Response

  4 weeks

Study Arms (2)

loteprednol etabonate 1% group

EXPERIMENTAL

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

prednisolone acetate 1% group

ACTIVE COMPARATOR

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%

Interventions

loteprednol etabonate 1% arm 1 DRUG

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.

loteprednol etabonate 1% group

prednisolone acete 1% DRUG

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.

prednisolone acetate 1% group

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum university Hospital

Al Fayyum, Faiyum Governorate, 63514, Egypt

Location

MeSH Terms

Conditions

Uveitis, Anterior

Interventions

Loteprednol Etabonate

Condition Hierarchy (Ancestors)

Panuveitis; Uveitis; Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of ophthalmology

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: August 10, 2025
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-02

Locations

EG (1)