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

Study Overview
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Brief Summary
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To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment, 0.5% vs. vehicle for the treatment of inflammation following cataract surgery

Official Title
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A Randomized Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate Ophthalmic Ointment, 0.5% Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery

Conditions
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Ocular Inflammation

Intervention / Treatment
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* Drug: 0.5% Loteprednol Etabonate Ophthalmic Ointment
* Drug: Vehicle of Loteprednol Etabonate Ophthalmic Ointment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loteprednol Etabonate<br>Loteprednol etabonate 0.5% ophthalmic ointment | Drug: 0.5% Loteprednol Etabonate Ophthalmic Ointment<br>* 1/2 inch ribbon four times a day for 14 days<br>|
| Placebo Comparator: Vehicle<br>Vehicle of loteprednol etabonate ointment | Drug: Vehicle of Loteprednol Etabonate Ophthalmic Ointment<br>* 1/2 inch ribbon four times a day for 14 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. Grade=0. | 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. | Postoperative Day 8 (Visit 5) | 
| Grade 0 for Pain | 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 | Postoperative Day 8 (Visit 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects With Complete Resolution of Anterior Chamber Cells and Flare. At Each Follow-up Visit. | 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. | At each follow-up visit through day18 (Visit 7) | 
| Change From Baseline to Each Follow-up Visit in Anterior Chamber Cells and Flare | 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. | Baseline and each follow-up visit through day18 (Visit 7) |