Comparing Optical Coherence Tomography (OCT) and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care

Study Overview
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Brief Summary
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To compare the efficacy of twice-daily topical bromfenac (Xibrom) ophthalmic solution alone versus twice-daily topical Xibrom with prednisolone acetate 1% three-times daily on visual acuity and OCT measurements.

Official Title
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A Prospective, Randomized Single-Masked Clinical Trial Comparing OCT and Visual Acuity Outcomes in Subjects Undergoing Cataract Surgery, Who Receive Xibrom Ophthalmic Solution and Standard Presurgical Care vs. Xibrom Ophthalmic Solution Plus Prednisolone Acetate 1% and Standard Presurgical Care

Conditions
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Cataracts

Intervention / Treatment
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* Drug: Xibrom, and Optive
* Drug: Xibrom and Pred Forte


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female at least 18 years of age. Expectation of 20/25 best corrected visual acuity (BCVA) post-operatively. Patients should be in good general health and devoid of recognized risk factors for CME. Patients with systemic diseases are eligible only if there were no ocular manifestations of the disease (specifically diabetics without retinopathy) Patients must be likely to provide informed consent, take study medications as directed, and complete all study visits Only one eye of each treated patient may be included in the study Exclusion Criteria: Any known contraindications to any study medication or their component Presence of uncontrolled systemic disease Required use of other ocular medications during the study o Artificial tears may be used Diabetics with any clinically evident or history of retinopathy Individuals with age-related macular changes, epi-retinal membranes, other retino-vascular diseases and/or other macular disorders thought to have a less than 20/25 surgical outcome expectation Abnormal pre-operative OCT (if obtainable)

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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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Group 1: Xibrom, Optive | Drug: Xibrom, and Optive<br>* Xibrom: two drops a day, three days before surgery and 21 days after surgery. Optive: three times a day for 21 days after surgery.<br>|
| Active Comparator: 2<br>Group 2: Xibrom, Pred Forte | Drug: Xibrom and Pred Forte<br>* Xibrom: two drops a day, three days before surgery and 21 days after surgery. Pred Forte: three times a day for 21 days after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT |  | 2-4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity |  | 2-4 months |