Phase 3
N=405
Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
Ocular Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT00699153 ↗Enrolled (actual)
405
Serious AEs
1.5%
Results posted
Sep 2010
Primary outcome: Primary: Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 — 64; 23 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Loteprednol Etabonate (Drug); Vehicle of Ophthalmic Loteprednol Etabonate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 |
64; 23 | — |
| PRIMARY Participants With Grade 0 (no) Pain |
149; 83 | — |
| SECONDARY Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each Visit. |
10; 9; 64; 23; 107; 42 | — |
| SECONDARY Mean Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare |
-1.2; -0.6; -2.2; -0.8; -2.7; -1.1 | — |
Summary
Evaluation of the clinical safety and efficacy of loteprednol etabonate in an ophthalmic base, when compared to vehicle for the treatment of inflammation following cataract surgery.
Eligibility Criteria
Inclusion Criteria
- Subjects at least 18 years of age
- Subjects who have the ability to understand and sign an informed consent form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Subjects who are candidate for routine, uncomplicated cataract surgery.
- Subjects who are not of childbearing potential or subjects who have a negative urine pregnancy test result at screening.
- Subjects must be willing and able to comply with all treatment and follow- up procedures.
Exclusion Criteria
- Subjects who have known hypersensitivity or contraindication to the study drug or its components.
- Subjects who have a history or presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject or compound the result of the study.
- 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 elevated intraocular pressure (>/= 21 mm 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.
- Subjects who have had ocular surgery in the study eye within 3 months or in the fellow eye within 2 weeks prior to the screening visit.
- Women who are pregnant or breast feeding.
- Subjects who have participated in an investigational drug or device study within the last 30 days.
- Subjects previously randomized in this study.
Data sourced from ClinicalTrials.gov (NCT00699153). 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.