Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas

Fayoum University

Status and phase: Completed; Phase 4

Conditions: Anterior Chamber Granulomatous Uveitis

Treatments: Drug: loteprednol etabonate 1% arm 1; Drug: prednisolone acete 1%

Study type: Interventional

Funder types: Other

Identifiers

NCT07496060

R824

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 4 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

loteprednol etabonate 1% group

Experimental group

Description:

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.

Treatment:

Drug: loteprednol etabonate 1% arm 1

prednisolone acetate 1% group

Active Comparator group

Description:

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.

Treatment:

Drug: prednisolone acete 1%