Phase 3
Completed N=107
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
Source: ClinicalTrials.gov NCT01475643 ↗Enrolled (actual)
107
Serious AEs
2.8%
Results posted
Jun 2019
Primary outcomePrimary: Anterior Chamber Inflammation — .913; .783 grade of anterior chamber cells
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anterior Chamber Inflammation |
.913; .783 | — |
| SECONDARY Anterior Chamber Cells & Flare |
.192; .341 | — |
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. Informational only — not medical advice.