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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2017-07-31

Brief Summary

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

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Detailed Description

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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

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Loteprednol etabonate

Loteprednol etabonate 0.5%

Group Type EXPERIMENTAL

Loteprednol etabonate

Intervention Type DRUG

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 acetate

Prednisolone acetate 1.0%

Group Type ACTIVE_COMPARATOR

Prednisolones acetate

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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LE PA

Eligibility Criteria

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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.

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No