Status:
COMPLETED
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Cataract
Eligibility:
All Genders
Up to 11 years
Phase:
PHASE3
Brief 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.
Detailed 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 ocu...
Eligibility Criteria
Inclusion
- Subject is a candidate for routine, uncomplicated surgery for childhood cataract
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT01475643
Start Date
June 1 2013
End Date
July 1 2017
Last Update
June 11 2019
Active Locations (1)
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1
Bausch & Lomb Inc
Rochester, New York, United States, 14609