Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery

Phase 3

Completed

Interventions: Drug: Vehicle of Loteprednol Etabonate Ophthalmic Ointment
Drug: 0.5% Loteprednol Etabonate Ophthalmic Ointment

Brief 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle of Loteprednol Etabonate Ophthalmic Ointment	Vehicle of loteprednol etabonate ointment
Loteprednol Etabonate	0.5% Loteprednol Etabonate Ophthalmic Ointment	Loteprednol etabonate 0.5% ophthalmic ointment

Primary Outcome Measures

Name	Time	Method
Grade 0 for Pain	Postoperative Day 8 (Visit 5)	Pain: A positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. Grade 0 = None; 1=Minimal; 2=Mild; 3=Moderate; 4=Moderately Severe; 5=Severe
Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0.	Postoperative Day 8 (Visit 5)	A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.

Secondary Outcome Measures

Name	Time	Method
Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit.	At each follow-up visit through day18 (Visit 7)	A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.
Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare	Baseline and each follow-up visit through day18 (Visit 7)	A combination of the grades for inflammatory cells and flare in the anterior chamber. Cells: accumulation of white blood cells in aqueous. 0=No cells seen; 1=1-5 cells; 2=6-15 cells; 3=16-30 cells; 4= \>30 cells. Flare: Scattering of a slit lamp light beam when directed into the anterior chamber (Tyndall effect). 0=None; 1=Mild; 2=Moderate; 3=Severe; 4=Very severe.