Phase 3
Completed N=405
Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery
Ocular Inflammation
Source: ClinicalTrials.gov NCT00699153 ↗
Enrolled (actual)
405
Serious AEs
1.5%
Results posted
Sep 2010
Primary outcomePrimary: Participants With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0 — 64; 23 participants
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.
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 | — |
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. Informational only — not medical advice.