Phase 3
N=400
Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery
Ocular Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT00645671 ↗Enrolled (actual)
400
Serious AEs
1.3%
Results posted
Sep 2010
Primary outcome: Primary: Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. — 48; 27; 153; 172 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 0.5% Loteprednol Etabonate Ophthalmic Ointment (Drug); Vehicle of Loteprednol Etabonate Ophthalmic Ointment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. |
48; 27; 153; 172 | — |
| PRIMARY Grade 0 for Pain |
156; 90; 45; 109 | — |
| SECONDARY Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. |
10; 9; 48; 27; 84; 30 | — |
| SECONDARY Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare |
-1.0; -0.4; -2.1; -0.7; -2.6; -0.9 | — |
Summary
To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery
Eligibility Criteria
Inclusion Criteria
- Subjects who are candidate 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 will require concurrent ocular therapy with NSAIDs, mast cell stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or with ocular or systemic corticosteroids
- Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components
- Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye
- Subjects who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to the Screening Visit
Data sourced from ClinicalTrials.gov (NCT00645671). 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.