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

Bausch + Lomb

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Drug: Prednisolones acetate; Drug: Loteprednol etabonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01475643

670

Details and patient eligibility

About

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

Full 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.

Enrollment: 107 patients

Sex: All

Ages: Under 11 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 2 patient groups

Loteprednol etabonate

Experimental group

Description:

Loteprednol etabonate 0.5%

Treatment:

Drug: Loteprednol etabonate

Prednisolones acetate

Active Comparator group

Description:

Prednisolone acetate 1.0%

Treatment:

Drug: Prednisolones acetate