Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.

Study Overview
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Brief Summary
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The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.

Detailed Description
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The objective of this study is to compare the efficacy and safety of topical Loteprednol Etabonate (LE), 0.5%, to Prednisolone Acetate 1%, for the treatment of postoperative inflammation following ocular surgery for childhood cataract.

Official Title
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Safety and Efficacy of Topical Loteprednol Etabonate 0.5%, Versus Prednisolone Acetate 1%, for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract

Conditions
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Cataract

Intervention / Treatment
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* Drug: Loteprednol etabonate
* Drug: Prednisolones acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a candidate for routine, uncomplicated surgery for childhood cataract Exclusion Criteria: Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up. Subjects with glaucoma, ocular hypertension, or those receiving intraocular pressure (IOP) lowering therapy in either eye or systemically. Subjects with a history of steroid-induced IOP elevation in either eye. Subjects who have known hypersensitivity or other contraindication to the study drug(s) or any components in the drug formulation.

Ages Eligible for Study
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Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loteprednol etabonate<br>Loteprednol etabonate 0.5% | Drug: Loteprednol etabonate<br>* 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.<br>* Other names: LE;|
| Active Comparator: Prednisolones acetate<br>Prednisolone acetate 1.0% | Drug: Prednisolones acetate<br>* 1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.<br>* Other names: PA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Inflammation | Anterior Chamber Inflammation (for subjects that could only be examined with a pen light and a 20D [g20 Diopter] magnifying lens): 0 = None Clear anterior chamber with no visible clouding (Tyndall effect and cells combined). Red reflex normal = Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal = Moderate Moderate anterior chamber clouding = Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished = Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished | Postoperative Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Cells & Flare | Anterior Chamber Flare (for those subjects that could be examined with a slit lamp): Assessed scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0 = None No Tyndall effect = Mild Tyndall effect barely discernible = Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly = Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly = Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance | Over all visits 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric cataract