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

Information source: Bausch & Lomb Incorporated
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataract

Intervention: Loteprednol etabonate (Drug); Prednisolones acetate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bausch & Lomb Incorporated

Official(s) and/or principal investigator(s):
Johnson Varughese, Study Director, Affiliation: Valeant/Bausch & Lomb

Overall contact:
Johnson Varughese, Phone: 908-927-1162, Email: johnson.varughese@valeant.com


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Anterior Chamber Inflammation

Secondary outcome: Anterior Chamber Cells & Flare


Minimum age: N/A. Maximum age: 11 Years. Gender(s): Both.


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 and Contacts

Johnson Varughese, Phone: 908-927-1162, Email: johnson.varughese@valeant.com

Bausch & Lomb Inc, Rochester, New York 14609, United States; Recruiting
Additional Information

Starting date: July 2013
Last updated: February 13, 2015

Page last updated: August 23, 2015

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