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

Last updated: June 10, 2019
Sponsor: Bausch & Lomb Incorporated
Overall Status: Completed

Phase

3

Condition

Uveitis

Vision Loss

Inflammation

Treatment

N/A

Clinical Study ID

NCT01475643
670
  • Ages < 11
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject is a candidate for routine, uncomplicated surgery for childhood cataract

Exclusion

Exclusion Criteria:

  • Subjects who have a severe/serious ocular condition, or any other unstable medicalcondition that, in the Investigator's opinion, may preclude study treatment orfollow-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 studydrug(s) or any components in the drug formulation.

Study Design

Total Participants: 107
Study Start date:
June 01, 2013
Estimated Completion Date:
July 31, 2017

Study 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.

Connect with a study center

  • Bausch & Lomb Inc

    Rochester, New York 14609
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.