Anterior Chamber Granulomatous UveitisPhase 4NCT07496060
Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas
A Phase 4 study testing loteprednol etabonate 1% arm 1 and prednisolone acete 1% in people with Anterior Chamber Granulomatous Uveitis, run by Fayoum University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 21 years
- Conditions the study is for
- Anterior Chamber Granulomatous Uveitis
- What is being tested?
- loteprednol etabonate 1% arm 1 and prednisolone acete 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2025to 13 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Anterior Chamber Granulomatous Uveitis
- Being tested
- loteprednol etabonate 1% arm 1, prednisolone acete 1%
- Keywords
- anterior chamber granuloma, anterior uveitis, loteprednol etabonate, prednisolone acetate
- Medical subject headings
- Uveitis, Anterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
loteprednol etabonate 1% arm 1Drug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: prednisolone acete 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 weeks
Secondary outcomes (3)
mean intraocular pressure change
Comparison of the mean IOP between the two treatment groups using Goldmann applanation tonometry
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start10 Aug 2025
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Chamber Granulomatous UveitisStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Abdul Fattah Saad, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496060
- Sponsor's protocol ID
- R824
- Status last verified
- Feb 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loteprednol Etabonate Versus Prednisolone Acetate for Anterior Chamber Granulomas: A Randomized Study
- ClinicalTrials.gov ID
- NCT07496060
- Acronym / sponsor ID
- R824
- Conditions
- Anterior Chamber Granulomatous Uveitis
- Keywords
- anterior chamber granuloma, anterior uveitis, loteprednol etabonate, prednisolone acetate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| loteprednol etabonate 1% group | Experimental | Drug: loteprednol etabonate 1% arm 1Participants 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. |
| prednisolone acetate 1% group | Active comparator | Drug: prednisolone acete 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. |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| loteprednol etabonate 1% arm 1Topical 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. | Drug | loteprednol etabonate 1% group |
| 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. | Drug | prednisolone acetate 1% group |
Primary outcome
resolution of the anterior chamber inflammation and granulomas.
Time frame: 4 weeks
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).
3 secondary outcomes
mean intraocular pressure change
Time frame: 1 month and 3 month
Incidence of Steroid-Related IOP Elevation
Time frame: throughout 3 months
Rate of Pharmacological Non-Response
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing loteprednol etabonate 1% arm 1 and prednisolone acete 1% in people with Anterior Chamber Granulomatous Uveitis, run by Fayoum University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
resolution of the anterior chamber inflammation and granulomas. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.