VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

Study Overview
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Brief Summary
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The purpose of this study is to compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection.

Official Title
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Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery

Conditions
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Cataracts

Intervention / Treatment
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* Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)
* Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older. Diagnosis of cataract with intention to undergo routine, uncomplicated cataract surgery. Able to understand and sign an informed consent form. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Glaucoma or ocular hypertension. Use of topical or systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to surgery or planned use during the study. Low-dose acetylsalicylic acid (up to 100 mg/day) is allowed. Use of anti-bacterial, anti-viral, or anti-fungal agents or ocular medications within 30 days prior to enrollment in the study or during study, as specified by protocol. Secondary implantation or replacement of the intra-ocular lens (IOL) in the study eye. Planned use of contact lenses in the study eye during the study period. Cataract surgery in the contralateral eye within 30 days prior to the Screening Visit, or planned for the 3 weeks after the cataract surgery in the study eye. History of clinically significant trauma to the study eye within the past 12 months. Other protocol-defined exclusion criteria may apply.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIGADEXA Gel<br>VIGADEXA ophthalmic gel topically administered TID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery. | Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)<br>* One ribbon (approximately 1-1.5 cm) administered topically in the conjunctival sac of the study eye three times daily (TID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.<br>* Other names: FID 119149, VIGADEXA Gel;|
| Active Comparator: VIGADEXA Solution<br>VIGADEXA ophthalmic solution topically administered QID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery. | Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)<br>* One drop administered topically in the conjunctival sac of the study eye four times daily (QID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.<br>* Other names: VIGADEXA Solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber | As assessed by the investigator during slit-lamp examination. | Day 15 post-operative | 
| Percentage of patients with no clinically evidenced bacterial infection | As assessed by the investigator during slit-lamp examination. | Day 15 post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cells in the anterior chamber (study eye) | As assessed by the investigator during slit-lamp examination. | Day 15 post-operative | 
| Ocular pain (study eye) | As assessed by the investigator during patient interview. | Day 15 post-operative | 
| Inflammatory reaction (study eye) | As assessed by the investigator during slit-lamp examination. | Day 15 post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract surgery, Topical therapy, Prevention of inflammation, Inflammation of infection