Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Loteprednol Etabonate in an Ophthalmic Base vs Vehicle for the Treatment of Inflammation Following Cataract Surgery

Conditions
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Ocular Inflammation

Intervention / Treatment
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* Drug: Loteprednol Etabonate
* Drug: Vehicle of Ophthalmic Loteprednol Etabonate


Participation Criteria
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Eligibility Criteria
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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.

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% | Drug: Loteprednol Etabonate<br>* Loteprednol Etabonate in an ophthalmic base will be administered to study eye 4 times a day(QID) for 14 days.<br>|
| Placebo Comparator: Vehicle<br>Vehicle of Ophthalmic Loteprednol Etabonate | Drug: Vehicle of Ophthalmic Loteprednol Etabonate<br>* Vehicle of ophthalmic loteprednol etabonate administered postoperatively to study eye 4 times a day(QID) for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants 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) | 
| Participants With Grade 0 (no) 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 |
| --- | --- | --- |
| Participants With Complete Resolution of Anterior Chamber Cells and Flare, at Each 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 visit: Visit 4-7, postoperative days 3-18 | 
| Mean 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. | Postoperative Day 3-18 (Each follow-up Visit 4-7) |