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

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00870103
First received: September 26, 2008
Last updated: March 3, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Cataract
Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • The Percentage of Patients With a Score of Zero for Anterior Chamber Cells. [ Time Frame: Day 15 after cataract surgery ] [ Designated as safety issue: Yes ]

    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


  • The Percentage of Patients With no Ocular Pain [ Time Frame: Day 15 after cataract surgery ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: September 2008
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870103

Locations
United States, Texas
Alcon Call Center
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Benny Li, Regional Scientific Clinical Affair Manager, Alcon Research Ltd.
ClinicalTrials.gov Identifier: NCT00870103     History of Changes
Other Study ID Numbers: RM-08-05
Study First Received: September 26, 2008
Results First Received: January 14, 2010
Last Updated: March 3, 2010
Health Authority: Philippines: Ministry of Health

Keywords provided by Alcon Research:
Cataract

Additional relevant MeSH terms:
Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Moxifloxacin
Tetrahydrozoline
BB 1101
Norgestimate, ethinyl estradiol drug combination
Ophthalmic Solutions
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014