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Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery

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ClinicalTrials.gov Identifier: NCT00870103
Recruitment Status : Completed
First Posted : March 26, 2009
Results First Posted : February 15, 2010
Last Update Posted : March 9, 2010
Sponsor:
Information provided by:
Alcon Research

Study Description
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Brief Summary:
To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.

Condition or disease Intervention/treatment Phase
Cataract Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of the Prophylactic Efficacy and Safety of the Administration of the Combination Formulation of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops in Inflammation and Infection Post-cataract Surgery
Study Start Date : September 2008
Actual Primary Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: Vigadexa eye drops
Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
 Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
1 drop every 6 hours into the study eye


Outcome Measures
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Primary Outcome Measures :
  1. The Percentage of Patients With a Score of Zero for Anterior Chamber Cells. [ Time Frame: Day 15 after cataract surgery ]

    The percentage of patients with a score of zero for Anterior chamber cells.

    Anterior chamber inflammation was evaluated based on the number of cells per high-power field measured using the narrowest slit beam of the lamp (0.5 at a height of 8mm).

    Anterior chamber cells was recorded on a 0-4 point scale,0 = Less than 5 cells; 1 = Mild: 5-10 cells; 2 = Moderate:11-20 cells; 3 = Marked: 21-50 cells; 4 = Severe: Greater than 50 cells / hypopyon


  2. The Percentage of Patients With no Ocular Pain [ Time Frame: Day 15 after cataract surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≧18 years of age
  • able to sign an informed consent and complete all required visits
  • intends to have a cataract extraction surgery followed by implantation of a posterior chamber Intraocular lens (IOL)
  • Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg)

Exclusion Criteria:

  • Uncontrolled glaucoma or IOP
  • use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of IOL in the study eye
  • use of steroid during the study or within 14 days prior to enrollment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870103


Locations
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United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information
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Responsible Party: Benny Li, Regional Scientific Clinical Affair Manager, Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00870103    
Other Study ID Numbers: RM-08-05
First Posted: March 26, 2009    Key Record Dates
Results First Posted: February 15, 2010
Last Update Posted: March 9, 2010
Last Verified: March 2010
Keywords provided by Alcon Research:
Cataract
Additional relevant MeSH terms:
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Cataract
Inflammation
Pathologic Processes
Lens Diseases
Eye Diseases
Moxifloxacin
Dexamethasone
Ophthalmic Solutions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions