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Completed

NCT Number: NCT01475643

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

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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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

Up to 11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bausch & Lomb Inc

Rochester, New York, 14609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Loteprednol Etabonate

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.

Other names: LE

Prednisolones acetate

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.

Other names: PA

Primary outcomes

  1. Anterior Chamber Inflammation

    Time frame: 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

    • = Mild Mild anterior chamber clouding. Clear iris pattern on visualization. Red reflex normal
    • = Moderate Moderate anterior chamber clouding
    • = Severe Severe anterior chamber clouding. Iris pattern not clearly visualized. Red reflex diminished
    • = Very severe Severe anterior chamber clouding with a white and/or milky appearance of the anterior chamber. Red reflex absent or severely diminished

Secondary outcomes

  1. Anterior Chamber Cells & Flare

    Time frame: 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

    • = Mild Tyndall effect barely discernible
    • = Moderate Tyndall effect in anterior chamber is moderately intense. Iris pattern is seen clearly
    • = Severe Tyndall effect in anterior chamber is severely intense. Iris pattern cannot be seen clearly
    • = Very severe Tyndall effect is very severely intense. The aqueous has a white and milky appearance

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 21, 2011
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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