Phase 3
N=107
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT01475643 ↗Enrolled (actual)
107
Serious AEs
2.8%
Results posted
Jun 2019
Primary outcome: Primary: Anterior Chamber Inflammation — .913; .783 grade of anterior chamber cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Loteprednol etabonate (Drug); Prednisolones acetate (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anterior Chamber Inflammation |
.913; .783 | — |
| SECONDARY Anterior Chamber Cells & Flare |
.192; .341 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT01475643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.