VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery

Phase 3

Withdrawn

• Conditions: Cataracts
• Interventions: Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel); Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)

• Registration Number: NCT01515826
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-24
• Status Verified: 2014-03
• Study Start: 2014-03
• Last Update Submitted: 2014-03-24
• Last Update Posted: 2014-03-26
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIGADEXA Gel	Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)	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.
VIGADEXA Solution	Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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