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

Bausch & Lomb Incorporated107 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

107

Conditions

Cataract

Interventions

Loteprednol etabonateDRUG

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.

Prednisolones acetateDRUG

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.

Eligibility

Sex: ALLMax age: 11 Years

Medical Language ↔ Plain English

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.

Locations (1)

Bausch & Lomb Inc

Rochester, New York, United States

Outcomes

Primary Outcomes

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 1. = Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal 2. = Moderate Moderate anterior chamber clouding 3. = Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished 4. = Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished

Time frame: Postoperative Day 29

Secondary Outcomes

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 1. = Mild Tyndall effect barely discernible 2. = Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly 3. = Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly 4. = Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance

Time frame: Over all visits 42 days

Data from ClinicalTrials.gov

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