Phase 3
N=406
Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
Inflammation · Pain
Bottom Line
View on ClinicalTrials.gov: NCT01010633 ↗Enrolled (actual)
406
Serious AEs
0.7%
Results posted
Jan 2012
Primary outcome: Primary: Resolution of Anterior Chamber Cells (ACC). — 62; 33 Eyes — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vehicle of Loteprednol Etabonate (Drug); Loteprednol Etabonate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resolution of Anterior Chamber Cells (ACC). |
62; 33 | <0.001 sig |
| PRIMARY Grade 0 Pain |
148; 85 | <0.001 sig |
| SECONDARY Resolution of Anterior Chamber Cells. |
17; 11; 62; 33; 102; 44 | — |
Summary
This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.
Eligibility Criteria
Inclusion Criteria
- Subjects who are at least 18 years of age.
- Subjects who are candidates for routine, uncomplicated cataract surgery.
- Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.
Exclusion Criteria
- Subjects who have known hypersensitivity or contraindication to the study drug or components.
- Subjects with 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 elevated intraocular pressure (>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
- Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
Data sourced from ClinicalTrials.gov (NCT01010633). 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.