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 compared to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.

Conditions
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Inflammation, Pain

Intervention / Treatment
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* Drug: Vehicle of Loteprednol Etabonate
* Drug: 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. 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 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 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 | Drug: Loteprednol Etabonate<br>* 1 to 2 drops of study drug administered into the study eye, 4 times a day for approximately 14 days.<br>|
| Placebo Comparator: Vehicle<br>Vehicle of loteprednol etabonate | Drug: Vehicle of Loteprednol Etabonate<br>* 1 to 2 drops of vehicle administered into the study eye, 4 times a day for approximately 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Anterior Chamber Cells (ACC). | Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp. | Visit 5 (Postoperative day 8) | 
| Grade 0 Pain | Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants. | Visit 5 (Postoperative Day 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Anterior Chamber Cells. | Study eyes with complete resolution of anterior chamber cells (ACC) | At visits 4-7- postoperative day 3, 8,15 & 18 |