NCT01475643

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Loteprednol etabonate	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.
DRUG	Prednisolones acetate	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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2017-06-02
• Completion: 2017-07-01
• First posted: 2011-11-21
• Last updated: 2019-06-11
• Results posted: 2019-06-11

Locations

1 site across 1 country: United States