Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

Study Overview
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Brief Summary
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This study is being conducted to compare the safety and efficacy of loteprednol etabonate to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

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

Conditions
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Inflammation, Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who are at least 18 years of age. Subjects who are candidates for routine, uncomplicated cataract surgery. Exclusion Criteria: Subjects who have known hypersensitivity or contraindication to the study drug or components. Subjects with 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 (>/=21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye. Subjects who are monocular or have pinholed Snellen visual acuity (VA) 20/200 or worse in the non-study eye.

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 suspension | Drug: Loteprednol etabonate<br>* Topical administration of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye four times a day (QID), postoperative day 1-14.<br>|
| Placebo Comparator: Vehicle<br>Vehicle of loteprednol etabonate ophthalmic suspension | Drug: Vehicle of Loteprednol Etabonate<br>* Topical administration of vehicle of loteprednol etabonate ophthalmic suspension 1-2 drops in study eye QID, postoperative day 1-14.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Anterior Chamber Cells. | Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells | Visit 5 (Postoperative day 8) | 
| Grade 0 Pain | Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain | Visit 5 (Postoperative day 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Anterior Chamber Cells | Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=>30 cells | Visit 4-7 (postoperative day 3-18) | 
| Grade 0 Pain | Participants with no pain, graded on a 0-5 scale, 0= no pain and 5=severe pain | Visits 4-7 (Postoperative days 3-18) | 
| Resolution of Anterior Chamber Flare | Complete resolution of flare, scored on a scale of 0-4 were 0=none and 4=very severe. | Visit 4-7 (postoperative day 3-18) |