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

Phase 3

Completed

• Conditions: Cataract
• Interventions: Drug: Prednisolones acetate; Drug: Loteprednol etabonate

• Registration Number: NCT01475643
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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

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 Timeline

• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-21
• Study Start: 2013-06
• Primary Completion: 2017-06-02
• Study Completion: 2017-07
• Results First Submitted: 2018-04-11
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-10
• Last Update Submitted: 2019-06-10
• Results First Posted: 2019-06-11
• Last Update Posted: 2019-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolones acetate	Prednisolones acetate	Prednisolone acetate 1.0%
Loteprednol etabonate	Loteprednol etabonate	Loteprednol etabonate 0.5%

Primary Outcome Measures

Name	Time	Method
Anterior Chamber Inflammation	Postoperative Day 29	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

Secondary Outcome Measures

Name	Time	Method
Anterior Chamber Cells & Flare	Over all visits 42 days	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

Trial Locations

Locations (1)

Bausch & Lomb Inc; 🇺🇸 Rochester, New York, United States